Panels › Clinical Toxicology › Product code LES · Class 2
Fluorescent Immunoassay, Diphenylhydantoin
Regulation 862.3350
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LES
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 0 |
| Syva Co. | 2 | 0 |
| American Dade | 1 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Sclavo, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 1987 | K865102 | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS Sclavo, Inc. | LES |
| Jan 23, 1985 | K844990 | SYVA ADVANCE EMIT PHENYTOIN ASSAY Syva Co. | LES |
| May 16, 1983 | K831154 | STRATUS PHENYTOIN FLUOROMETRIC ENZYME American Dade | LES |
| Feb 12, 1982 | K820187 | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY Syva Co. | LES |
| Dec 31, 1981 | K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LES |
| Apr 29, 1981 | K811025 | AMES TDA TM PHENYTOIN TEST Miles Laboratories, Inc. | LES |
| Aug 20, 1980 | K801736 | AMES TDA TM PHENYTOIN TEST Miles Laboratories, Inc. | LES |
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