The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Quick-check Ii Reagent Strip.
| Device ID | K921825 |
| 510k Number | K921825 |
| Device Name: | QUICK-CHECK II REAGENT STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DIAGNOSTIC SOLUTIONS, INC. 27071 CABOT RD. SUITE 101 Laguna Hills, CA 92653 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. 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 | 1992-04-16 |
| Decision Date | 1992-08-18 |