Panels › Clinical Toxicology › Product code LFT · Class 2
Fluorescent Immunoassay, Primidone
Regulation 862.3680
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LFT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1995 | K950028 | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS Sigma Diagnostics, Inc. | LFT |
| Nov 28, 1990 | K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME Baxter Healthcare Corp | LFT |
| Oct 20, 1989 | K895567 | PRIMIDONE (FPIA) KIT Tudor Laboratories, Inc. | LFT |
| Jun 25, 1985 | K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS Roche Diagnostic Systems, Inc. | LFT |
| Jul 11, 1984 | K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY American Dade | LFT |
| Jan 7, 1983 | K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY Syva Co. | LFT |
| Aug 12, 1982 | K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LFT |
| Apr 29, 1981 | K811007 | AMES TDA TM PRIMIDONE TEST Miles Laboratories, Inc. | LFT |
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