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EliA GBM Well

Model DECC055140 · Phadia AB · DI 07333066014630

MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) · Class II · 21 CFR 866.5660

UDILibrary device dossier · generated 2026-09-15 · 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.

01112025-06: 0 reports for this device; peer average 1/device06
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-0601
This device (reports/month)Average device in MVJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K140225 — cites (transitively): K974169 (d1), K981328 (d1), K981330 (d1) — cited as predicate by K173792, K182774

K173792 — cites (transitively): K140225 (d1), K974169 (d2), K981328 (d2), K981330 (d2)

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

Manufacturer compliance record — Phadia AB

  • NAI 2013-11-21 Phadia GmbH · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations