K932871 is an FDA 510(k) clearance for the UIBC FOR DISCREET RANDOM ACCESS ANALYZER. This device is classified as a Bathophenanthroline, Colorimetry, Iron (non-heme) (Class I - General Controls, product code CFM).
Submitted by Catachem, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 8, 1993, 86 days after receiving the submission on June 14, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K932871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1993 |
| Decision Date | September 08, 1993 |
| Days to Decision | 86 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 |