Panels › Clinical Toxicology › Product code LET · Class 2
Fluorescent Immunoassay, Phenobarbital
Regulation 862.3660
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 LET
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 0 |
| American Dade | 1 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Pb Diagnostic Systems, Inc. | 1 | 0 |
| Sclavo, Inc. | 1 | 0 |
| Syva Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 1990 | K901537 | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM Pb Diagnostic Systems, Inc. | LET |
| Feb 6, 1987 | K865000 | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS Sclavo, Inc. | LET |
| Aug 17, 1984 | K842592 | AMES TDA PHENOBARBITAL TEST Miles Laboratories, Inc. | LET |
| May 13, 1983 | K830701 | STRATUS PHENOBARBITAL FLUOROMETRIC ENZ American Dade | LET |
| May 24, 1982 | K821408 | PHENOBARBITAL FLUORESCENT IMMUNO American Diagnostic Corp. | LET |
| Feb 5, 1982 | K820188 | PHENOBARBITAL ASSAY Syva Co. | LET |
| Apr 29, 1981 | K810994 | AMES TDA TM PHENOBARBITAL TEST Miles Laboratories, Inc. | LET |
| Sep 26, 1980 | K802255 | AMES TDA PHENOBARBITAL TEST Miles Laboratories, Inc. | LET |
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