Submission Details
| 510(k) Number | K001403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 2000 |
| Decision Date | August 10, 2000 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
Aug 2000
Decision
99d
Days
Class 2
Risk
About This 510(k) Submission
K001403 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 10, 2000, 99 days after receiving the submission on May 3, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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