K943702 is an FDA 510(k) clearance for the AVL 988-4 ELECTROLYTE ANALYZER. This device is classified as a Electrode, Ion Specific, Calcium (Class II - Special Controls, product code JFP).
Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on September 9, 1994, 42 days after receiving the submission on July 29, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K943702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1994 |
| Decision Date | September 09, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFP — Electrode, Ion Specific, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |