The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Uni-check Reagent Strip.
| Device ID | K924398 |
| 510k Number | K924398 |
| Device Name: | UNI-CHECK REAGENT STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DIAGNOSTIC SOLUTIONS, INC. 27071 CABOT RD. SUITE 101 Laguna Hills, CA 92653 |
| Contact | Chen |
| Correspondent | Chen DIAGNOSTIC SOLUTIONS, INC. 27071 CABOT RD. SUITE 101 Laguna Hills, CA 92653 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1992-12-23 |