The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Cannabinoid Eia Assay.
| Device ID | K943998 |
| 510k Number | K943998 |
| Device Name: | CANNABINOID EIA ASSAY |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View, CA 94041 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005689 | K943998 | 000 |
| 00884883003484 | K943998 | 000 |
| 00380740165192 | K943998 | 000 |