K931362 is an FDA 510(k) clearance for the IL TEST CALCIUM. This device is classified as a Cresolphthalein Complexone, Calcium (Class II - Special Controls, product code CIC).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 1, 1994, 321 days after receiving the submission on March 17, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K931362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1993 |
| Decision Date | February 01, 1994 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIC — Cresolphthalein Complexone, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |