The following data is part of a premarket notification filed by Bio-rad with the FDA for Benozodiazepines And Tricylic Antidepressants By Hplc.
| Device ID | K941990 |
| 510k Number | K941990 |
| Device Name: | BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC |
| Classification | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | John Nelson |
| Correspondent | John Nelson BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | LFI |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1995-03-20 |