K935192 is an FDA 510(k) clearance for the EMIT IIC CALIBRATORS. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on March 24, 1995, 514 days after receiving the submission on October 26, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K935192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1993 |
| Decision Date | March 24, 1995 |
| Days to Decision | 514 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |