The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set.
| Device ID | K150925 |
| 510k Number | K150925 |
| Device Name: | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Joseph Ginete |
| Correspondent | Joseph Ginete Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | DIO |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937101377 | K150925 | 000 |
| 00840937101353 | K150925 | 000 |
| 00840937101339 | K150925 | 000 |
| 00840937101315 | K150925 | 000 |