K880610 is an FDA 510(k) clearance for the UNIMETER CALIBRATION KIT. This device is classified as a Calibrator, Surrogate (Class II - Special Controls, product code JIW).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 24, 1988, 41 days after receiving the submission on February 12, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K880610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1988 |
| Decision Date | March 24, 1988 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIW — Calibrator, Surrogate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |