The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Uric Acid Reagent Set.
| Device ID | K812430 |
| 510k Number | K812430 |
| Device Name: | URIC ACID REAGENT SET |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-25 |
| Decision Date | 1981-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727012197 | K812430 | 000 |