The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis 6-acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-acetylmorphine Urine Calibrator, Immunalysis 6-acetylmorphine Urine Controls.
| Device ID | K150275 |
| 510k Number | K150275 |
| Device Name: | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Immunalysis Corporation 829 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Joseph Ginete |
| Correspondent | Joseph Ginete Immunalysis Corporation 829 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | DJG |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-04 |
| Decision Date | 2015-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111345 | K150275 | 000 |
| 00840937107676 | K150275 | 000 |
| 00840937107683 | K150275 | 000 |
| 00840937107690 | K150275 | 000 |
| 00840937107768 | K150275 | 000 |
| 00840937107775 | K150275 | 000 |
| 00840937110973 | K150275 | 000 |
| 00840937111031 | K150275 | 000 |
| 00840937111185 | K150275 | 000 |
| 00840937111321 | K150275 | 000 |
| 00840937111338 | K150275 | 000 |
| 00840937107669 | K150275 | 000 |