The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Multi Level Thc Assay, Synchron Cx Reagent Application.
| Device ID | K944562 |
| 510k Number | K944562 |
| Device Name: | MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy S Maddox |
| Correspondent | Betsy S Maddox MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1994-11-02 |