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BTA stat
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Model 661010 · UDI-DI 00855574005261
1
510(k) clearances
6
Adverse events
1
Recalls
5
Facilities
Description
BTA stat Test - 10 Test kit - Internationally Labeled
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-02-19 | Vysis | Some of the control slides did not have adequate cells deposited upon their surface. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.