K792376 is an FDA 510(k) clearance for the QUANTITATIVE CONTROL URINE II (HUMAN). This device is classified as a Urinalysis Controls (assayed And Unassayed) (Class I - General Controls, product code JJW).
Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 10 days after receiving the submission on November 26, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K792376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1979 |
| Decision Date | December 06, 1979 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJW — Urinalysis Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |