The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Uric Acid (liquid) Reagent Set.
| Device ID | K970560 |
| 510k Number | K970560 |
| Device Name: | URIC ACID (LIQUID) REAGENT SET |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters, Jr. |
| Correspondent | William F Walters, Jr. POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015136 | K970560 | 000 |
| 00811727016294 | K970560 | 000 |
| 00817439021342 | K970560 | 000 |
| 00817439021366 | K970560 | 000 |
| 00811727012166 | K970560 | 000 |
| 00811727012173 | K970560 | 000 |
| 00811727012180 | K970560 | 000 |
| 00811727012791 | K970560 | 000 |
| 00811727013125 | K970560 | 000 |
| 00811727013675 | K970560 | 000 |
| 00811727014450 | K970560 | 000 |
| 00811727014467 | K970560 | 000 |
| 00811727014849 | K970560 | 000 |
| 00811727015990 | K970560 | 000 |