K963537 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS BUN REAGENT. This device is classified as a Conductivity Rate, Urea Nitrogen (Class II - Special Controls, product code LFP).
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 FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K963537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LFP — Conductivity Rate, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |