The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Uric Acid Reagent Set.
| Device ID | K914158 |
| 510k Number | K914158 |
| Device Name: | URIC ACID REAGENT SET |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | TECH INTL. CO. 1856 STARR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1992-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002355 | K914158 | 000 |
| 10673486002348 | K914158 | 000 |
| 10673486002331 | K914158 | 000 |
| 10673486002324 | K914158 | 000 |
| 10673486002263 | K914158 | 000 |
| 00850053916168 | K914158 | 000 |