K895047 is an FDA 510(k) clearance for the CLINISTAT POTASSIUM REAGENT TEST. This device is classified as a Bathophenanthroline, Colorimetry, Iron (non-heme) (Class I - General Controls, product code CFM).
Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on October 17, 1989, 69 days after receiving the submission on August 9, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K895047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1989 |
| Decision Date | October 17, 1989 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFM — Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1410 |