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Syva® Emit® Calibrator/Control Level 5

Model 10445411 · Siemens Healthcare Diagnostics Inc. · DI 00842768001789

DIF — Drug Mixture Control Materials · Class I · 21 CFR 862.3280

DKB — Calibrators, Drug Mixture · Class II · 21 CFR 862.3200

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 1

01112024-11: 1 reports for this device11
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-111—
This device (reports/month)Average device in DIF, DKB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K993755 — cited as predicate by K150606

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Siemens Healthcare Diagnostics Inc.

  • Warning Letter 2012-06-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-06-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-29 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-10 Siemens Healthcare Diagnostics, Inc.
  • Warning Letter 2012-05-10 Siemens Healthcare Diagnostics, Inc.
  • NAI 2026-02-26 Siemens Healthcare Diagnostics Products Ltd. · 0 citations
  • NAI 2024-05-24 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2024-05-24 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2022-03-30 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2022-03-30 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • VAI 2022-03-08 Siemens Healthcare Diagnostics, Inc. · 2 citations
  • VAI 2022-03-08 Siemens Healthcare Diagnostics, Inc. · 2 citations
  • NAI 2021-08-19 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2021-08-19 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2021-03-12 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2021-03-12 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2019-03-18 Siemens Healthcare Diagnostics Inc. · 0 citations
  • NAI 2018-05-24 Siemens Healthcare Diagnostics Manufacturing Limited · 0 citations
  • VAI 2018-03-02 Siemens Healthcare Diagnostics, Inc. · 4 citations
  • VAI 2018-03-02 Siemens Healthcare Diagnostics, Inc. · 4 citations
  • NAI 2017-11-29 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2017-11-29 Siemens Healthcare Diagnostics, Inc. · 0 citations
  • NAI 2017-11-09 Siemens Healthcare Diagnostics Inc · 0 citations
  • NAI 2017-09-26 Siemens Healthcare Diagnostics Inc. · 0 citations
  • NAI 2017-08-25 Siemens Healthcare Diagnostics Inc. · 0 citations