The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Reagent For Uric Acid--modification.
| Device ID | K922762 |
| 510k Number | K922762 |
| Device Name: | ROCHE REAGENT FOR URIC ACID--MODIFICATION |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630922550 | K922762 | 000 |