K943595 is an FDA 510(k) clearance for the SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 28, 1994, 126 days after receiving the submission on July 25, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K943595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1994 |
| Decision Date | November 28, 1994 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |