The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Relief Plus One Reagent Strip Modification.
| Device ID | K934892 |
| 510k Number | K934892 |
| Device Name: | RELIEF PLUS ONE REAGENT STRIP MODIFICATION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DIAGNOSTIC SOLUTIONS, INC. 8 PASTEUR #100 Irvine, CA 92718 |
| Contact | S. T. Chen |
| Correspondent | S. T. Chen DIAGNOSTIC SOLUTIONS, INC. 8 PASTEUR #100 Irvine, CA 92718 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-20 |
| Decision Date | 1994-01-11 |