Submission Details
| 510(k) Number | K963541 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 1996 |
| Decision Date | October 24, 1996 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SIGMA DIAGNOSTICS CO2 ACID REAGENT
Oct 1996
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K963541 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS CO2 ACID REAGENT, a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 24, 1996, 50 days after receiving the submission on September 4, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.
Device Classification
| Product Code | JFL — Ph Rate Measurement, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
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