The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Glucose Reagent Set.
| Device ID | K914159 |
| 510k Number | K914159 |
| Device Name: | GLUCOSE REAGENT SET |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001761 | K914159 | 000 |
| 10673486001754 | K914159 | 000 |
| 10673486001778 | K914159 | 000 |
| 10673486001785 | K914159 | 000 |