The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Sefria Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators.
| Device ID | K161216 |
| 510k Number | K161216 |
| Device Name: | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | IMMUNALYSIS CORPORATION 829 TOWNE CENTER DRIVE Pomona, CA 91767 |
| Contact | Joseph Ginete |
| Correspondent | Michelle Bodien IMMUNALYSIS CORPORATION 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2017-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937111482 | K161216 | 000 |
| 00840937111000 | K161216 | 000 |
| 00840937108697 | K161216 | 000 |
| 00840937108673 | K161216 | 000 |
| 00840937108659 | K161216 | 000 |
| 00840937108635 | K161216 | 000 |