The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Tramadol Urine Enzyme Immunoassay.
| Device ID | K141803 |
| 510k Number | K141803 |
| Device Name: | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY |
| 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 | 2014-07-03 |
| Decision Date | 2015-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111598 | K141803 | 000 |
| 00840937107607 | K141803 | 000 |
| 00840937107614 | K141803 | 000 |
| 00840937107621 | K141803 | 000 |
| 00840937107645 | K141803 | 000 |
| 00840937107652 | K141803 | 000 |
| 00840937111024 | K141803 | 000 |
| 00840937111161 | K141803 | 000 |
| 00840937111178 | K141803 | 000 |
| 00840937111260 | K141803 | 000 |
| 00840937111567 | K141803 | 000 |
| 00840937111574 | K141803 | 000 |
| 00840937111581 | K141803 | 000 |
| 00840937107591 | K141803 | 000 |