K822237 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT SET (MOD. BERTHEL. This device is classified as a Berthelot Indophenol, Urea Nitrogen (Class II - Special Controls, product code CDL).
Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982, 19 days after receiving the submission on July 28, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K822237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1982 |
| Decision Date | August 16, 1982 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDL — Berthelot Indophenol, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |