The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Urine Heroin/morphine Direct Ria Kit (i-125).
| Device ID | K933572 |
| 510k Number | K933572 |
| Device Name: | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| 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 | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-23 |
| Decision Date | 1994-04-06 |