The following data is part of a premarket notification filed by General Diagnostics with the FDA for Benzodiazepine Enzyme Immunoassay Kit.
| Device ID | K863877 |
| 510k Number | K863877 |
| Device Name: | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Contact | Akerkar, Ph.d. |
| Correspondent | Akerkar, Ph.d. GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-06 |
| Decision Date | 1987-03-12 |