The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-drug Controls.
| Device ID | K143502 |
| 510k Number | K143502 |
| Device Name: | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug 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 | DLJ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937101476 | K143502 | 000 |
| 00840937101452 | K143502 | 000 |
| 00840937101513 | K143502 | 000 |
| 00840937101490 | K143502 | 000 |