Panels › Clinical Toxicology › Product code MRS · Class 1
Test System, Nicotine, Cotinine, Metabolites
Regulation 862.3220
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in MRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Dynagen, Inc. | 1 | 0 |
| Microgenics Corp. | 1 | 0 |
| Nymox Pharmaceutical Corporation | 1 | 0 |
| Polymer Technology Systems, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2020 | Polymer Technology Systems, Inc. PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 n Terminated |
MRS | None listed |
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