The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine Controls And Calibrators.
| Device ID | K141406 |
| 510k Number | K141406 |
| Device Name: | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS |
| 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 | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2014-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111376 | K141406 | 000 |
| 00840937102701 | K141406 | 000 |
| 00840937102718 | K141406 | 000 |
| 00840937102725 | K141406 | 000 |
| 00840937110980 | K141406 | 000 |
| 00840937111383 | K141406 | 000 |
| 00840937103876 | K141406 | 000 |
| 00840937103883 | K141406 | 000 |
| 00840937103890 | K141406 | 000 |
| 00840937111048 | K141406 | 000 |
| 00840937111055 | K141406 | 000 |
| 00840937111192 | K141406 | 000 |
| 00840937111352 | K141406 | 000 |
| 00840937111369 | K141406 | 000 |
| 00840937102695 | K141406 | 000 |