Submission Details
| 510(k) Number | K963538 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 1996 |
| Decision Date | October 11, 1996 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
Oct 1996
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K963538 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS CO2ALKALINE BUFFER, 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 11, 1996, 37 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
Similar Devices — JFL Ph Rate Measurement, Carbon-dioxide
All 27
K191298 · Abbott Point of Care, Inc.
· Feb 2020
K040975 · Genchem, Inc.
· Dec 2004
K014034 · Beckman Coulter, Inc.
· Dec 2001
K963541 · Sigma Diagnostics, Inc.
· Oct 1996
K963540 · Sigma Diagnostics, Inc.
· Sep 1996
K963005 · Nova Biomedical Corp.
· Aug 1996
More from Sigma Diagnostics, Inc.
View all
K021162
· JPA · Aug 2002
K020109
· GGC · Feb 2002
K013549
· DAP · Dec 2001
K013544
· DAP · Nov 2001
K013545
· DAP · Nov 2001