K882220 is an FDA 510(k) clearance for the CALIBRATION KIT. This device is classified as a Calibrator, Surrogate (Class II - Special Controls, product code JIW).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 2, 1988, 68 days after receiving the submission on May 26, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K882220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1988 |
| Decision Date | August 02, 1988 |
| Days to Decision | 68 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 |