K972363 is an FDA 510(k) clearance for the IL TEST IRON. This device is classified as a Photometric Method, Iron (non-heme) (Class I - General Controls, product code JIY).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 15, 1997, 51 days after receiving the submission on June 25, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K972363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1997 |
| Decision Date | August 15, 1997 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIY — Photometric Method, Iron (non-heme) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1410 |