Submission Details
| 510(k) Number | K992803 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 1999 |
| Decision Date | September 13, 1999 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
Sep 1999
Decision
25d
Days
Class 1
Risk
About This 510(k) Submission
K992803 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 13, 1999, 25 days after receiving the submission on August 19, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.
Device Classification
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Manufacturer
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