The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Cocaine/cocaine Metabolite Elisa For Oral Fluids.
| Device ID | K051578 |
| 510k Number | K051578 |
| Device Name: | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Immunalysis Corporation 829 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Michael Vincent |
| Correspondent | Michael Vincent Immunalysis Corporation 829 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-14 |
| Decision Date | 2005-11-18 |