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Research and Diagnostic Systems

Model HCT004 · RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · DI 00815762021046

JPK — Mixture, Hematology Quality Control · Class II · 21 CFR 864.8625

UDILibrary device dossier · generated 2026-09-12 · 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 (0)

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.

11222020-10: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device10031107
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1001
2021-0302
2021-1101
2023-0701
This device (reports/month)Average device in JPK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K073178 — cited as predicate by K151960

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

Manufacturer compliance record — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Nothing in the loaded window.