The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Ethyl Alcohol Calibrators & Control.
| Device ID | K924733 |
| 510k Number | K924733 |
| Device Name: | ETHYL ALCOHOL CALIBRATORS & CONTROL |
| Classification | Calibrators, Ethyl Alcohol |
| 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 | DNN |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-22 |
| Decision Date | 1992-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740005542 | K924733 | 000 |
| 00884883001039 | K924733 | 000 |
| 00884883005129 | K924733 | 000 |
| 00884883005198 | K924733 | 000 |
| 00884883011540 | K924733 | 000 |
| 00884883011564 | K924733 | 000 |
| 00380740005511 | K924733 | 000 |
| 00380740005528 | K924733 | 000 |
| 00380740005535 | K924733 | 000 |
| 00884883001015 | K924733 | 000 |