The following data is part of a premarket notification filed by Macomb Biotechnology, Inc. with the FDA for The Uric Acid Reagent Set.
| Device ID | K871902 |
| 510k Number | K871902 |
| Device Name: | THE URIC ACID REAGENT SET |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | MACOMB BIOTECHNOLOGY, INC. 70001 POWELL RD, P.O. BOX 466 Romeo, MI 48065 |
| Contact | Sally Holefca |
| Correspondent | Sally Holefca MACOMB BIOTECHNOLOGY, INC. 70001 POWELL RD, P.O. BOX 466 Romeo, MI 48065 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-15 |
| Decision Date | 1987-06-03 |