Panels › Clinical Toxicology › Product code LFN · Class 2
Nephelometric Inhibition Immunoassay, Phenobarbital
Regulation 862.3660
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LFN
| Company | 510(k)s | Recalls |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| Coulter Electronics, Inc. | 1 | 0 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 0 |
| Seradyn, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 1994 | K934388 | QMS PHENOBARBITAL Seradyn, Inc. | LFN |
| Jan 13, 1987 | K864612 | DART PHENOBARBITAL ASSAY SYSTEM Coulter Electronics, Inc. | LFN |
| Feb 28, 1986 | K860304 | DUPONT PHENOBARBITAL ASSAY E.I. Dupont DE Nemours & Co., Inc. | LFN |
| Feb 28, 1986 | K860303 | DUPONT PHENOBARBITAL CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | LFN |
| Jun 3, 1982 | K821543 | IPA FOR DETECTION OF PHENOBARBITAL Electro-Nucleonics Laboratories, Inc. | LFN |
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