The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Ethyl Alcohol Assay.
| Device ID | K923783 |
| 510k Number | K923783 |
| Device Name: | ETHYL ALCOHOL ASSAY |
| Classification | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
| 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 | DMT |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1993-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740135386 | K923783 | 000 |
| 00380740005559 | K923783 | 000 |
| 00884883012486 | K923783 | 000 |
| 00884883002890 | K923783 | 000 |
| 00884883001008 | K923783 | 000 |
| 00380740135393 | K923783 | 000 |