The following data is part of a premarket notification filed by General Diagnostics with the FDA for Quali. Enzyme Immuno. Of Barbiturates In Urine.
| Device ID | K864993 |
| 510k Number | K864993 |
| Device Name: | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE |
| 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 | 1986-12-22 |
| Decision Date | 1987-03-31 |