The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set.
| Device ID | K143500 |
| 510k Number | K143500 |
| Device Name: | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937103609 | K143500 | 000 |
| 00840937103586 | K143500 | 000 |
| 00840937103562 | K143500 | 000 |
| 00840937103548 | K143500 | 000 |
| 00840937103524 | K143500 | 000 |
| 00840937101742 | K143500 | 000 |
| 00840937101728 | K143500 | 000 |
| 00840937101704 | K143500 | 000 |
| 00840937101681 | K143500 | 000 |