The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-drug Calibrators.
| Device ID | K153693 |
| 510k Number | K153693 |
| Device Name: | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937101964 | K153693 | 000 |
| 00840937101940 | K153693 | 000 |
| 00840937101926 | K153693 | 000 |
| 00840937101902 | K153693 | 000 |