K935287 is an FDA 510(k) clearance for the IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM. This device is classified as a Photometric Method, Iron (non-heme) (Class I - General Controls, product code JIY).
Submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on January 3, 1994, 61 days after receiving the submission on November 3, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K935287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 61 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 |