The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Resubmission Of Urine Heroin/morphine Kit [i-125].
| Device ID | K871698 |
| 510k Number | K871698 |
| Device Name: | RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-06-15 |