The following data is part of a premarket notification filed by General Diagnostics with the FDA for Barbiturate Enzyme Immunoassay Kit.
| Device ID | K882663 |
| 510k Number | K882663 |
| Device Name: | BARBITURATE ENZYME IMMUNOASSAY KIT |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Contact | Susan M Durham |
| Correspondent | Susan M Durham GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-09-19 |