The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Uric Acid Reagent (product #88219).
| Device ID | K883404 |
| 510k Number | K883404 |
| Device Name: | URIC ACID REAGENT (PRODUCT #88219) |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Bentley Tam |
| Correspondent | Bentley Tam HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1988-09-13 |