The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Urine Cocaine Metabolite Direct Ria Kit (i-125).
| Device ID | K913867 |
| 510k Number | K913867 |
| Device Name: | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) |
| Classification | Radioimmunoassay, Cocaine Metabolite |
| Applicant | Immunalysis Corporation 1707 GARDENA AVE. Glendale, CA 91204 |
| Contact | James R Soares |
| Correspondent | James R Soares 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 | 1991-08-27 |
| Decision Date | 1991-09-19 |