The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Oxycodone Enzyme Immunoassay.
| Device ID | K131168 |
| 510k Number | K131168 |
| Device Name: | IMMUNALYSIS OXYCODONE 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 | 2013-04-24 |
| Decision Date | 2014-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111550 | K131168 | 000 |
| 00840937107744 | K131168 | 000 |
| 00840937103395 | K131168 | 000 |
| 00840937103388 | K131168 | 000 |
| 00840937103371 | K131168 | 000 |
| 00840937103364 | K131168 | 000 |
| 00840937103357 | K131168 | 000 |
| 00840937101087 | K131168 | 000 |
| 00840937101070 | K131168 | 000 |
| 00840937111017 | K131168 | 000 |
| 00840937111130 | K131168 | 000 |
| 00840937111147 | K131168 | 000 |
| 00840937111543 | K131168 | 000 |
| 00840937111536 | K131168 | 000 |
| 00840937111529 | K131168 | 000 |
| 00840937111512 | K131168 | 000 |
| 00840937111505 | K131168 | 000 |
| 00840937111253 | K131168 | 000 |
| 00840937111246 | K131168 | 000 |
| 00840937111154 | K131168 | 000 |
| 00840937101063 | K131168 | 000 |