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iScreen™
Instant Technologies, Inc. · Model DCT-B702 · UDI-DI 00817405022526
MRS
Prescription
3
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities
Description
iScreen COT Dev(Oral Fluid) 25T
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.