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Trinity Biotech
MARDX DIAGNOSTICS, INC. · Model 10-5404 · UDI-DI 05391516747790
0
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities
Description
Monkey Heart 4 Well Slides, 12 each/pack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-07-15 | BioCheck Inc | Products were marketed without 510(k) for diagnostic use. Unapproved device. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.