K913371 is an FDA 510(k) clearance for the TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 8, 1991, 102 days after receiving the submission on July 29, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K913371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1991 |
| Decision Date | November 08, 1991 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |