The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Multi-level Thc Assay, Hitachi 911 Reagent/ And The Hitachi 747 Reagent.
| Device ID | K940649 |
| 510k Number | K940649 |
| Device Name: | CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy Soares-maddox |
| Correspondent | Betsy Soares-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 | 1994-02-15 |
| Decision Date | 1994-05-17 |