The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Benzodiazepine Serum Tox Eia Test.
| Device ID | K960708 |
| 510k Number | K960708 |
| Device Name: | BENZODIAZEPINE SERUM TOX EIA TEST |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-21 |
| Decision Date | 1996-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011208 | K960708 | 000 |
| 00630414526928 | K960708 | 000 |
| 00884883005594 | K960708 | 000 |
| 00380740150655 | K960708 | 000 |