Submission Details
| 510(k) Number | K984574 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 1998 |
| Decision Date | February 11, 1999 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
INFINITY GLUCOSE REAGENT
Feb 1999
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K984574 is an FDA 510(k) clearance for the INFINITY GLUCOSE REAGENT, 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 February 11, 1999, 50 days after receiving the submission on December 23, 1998. 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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