The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-drug Calibrators.
| Device ID | K161714 |
| 510k Number | K161714 |
| Device Name: | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-21 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937101827 | K161714 | 000 |
| 00840937101803 | K161714 | 000 |
| 00840937101780 | K161714 | 000 |
| 00840937101766 | K161714 | 000 |