Submission Details
| 510(k) Number | K992798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 1999 |
| Decision Date | September 28, 1999 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
Sep 1999
Decision
40d
Days
Class 1
Risk
About This 510(k) Submission
K992798 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P, a Acid, Uric, Uricase (u.v.) (Class I — General Controls, product code CDO), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 28, 1999, 40 days after receiving the submission on August 19, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.
Device Classification
| Product Code | CDO — Acid, Uric, Uricase (u.v.) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1775 |
Manufacturer
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