K980757 is an FDA 510(k) clearance for the ILAB 600 CLINICAL CHEMISTRY SYSTEM. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on April 21, 1998, 53 days after receiving the submission on February 27, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K980757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1998 |
| Decision Date | April 21, 1998 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |