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Areta Cotinine Test Strip -COT(10 tests one kit)
EASY HEALTHCARE CORPORATION · Model ASCOT-114C · UDI-DI 00810038634654
3
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities
Description
10 tests kit; COT Single Drug Screen Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-21 | Polymer Technology Systems, Inc. | The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. |
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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.