The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Resub. Urine Cocaine Meta. Direct Ria Kit [i-125].
| Device ID | K871549 |
| 510k Number | K871549 |
| Device Name: | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] |
| Classification | Radioimmunoassay, Cocaine Metabolite |
| Applicant | Immunalysis Corporation 1707 GARDENA AVE. Glendale, CA 91204 |
| Contact | Soares, Phd |
| Correspondent | Soares, Phd Immunalysis Corporation 1707 GARDENA AVE. Glendale, CA 91204 |
| Product Code | KLN |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-06-16 |