K912912 is an FDA 510(k) clearance for the SYNERMED SERUM IRON-600 REAGENT KIT. This device is classified as a Bathophenanthroline, Colorimetry, Iron (non-heme) (Class I - General Controls, product code CFM).
Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on July 30, 1991, 27 days after receiving the submission on July 3, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K912912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1991 |
| Decision Date | July 30, 1991 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CFM — Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1410 |