K912729 is an FDA 510(k) clearance for the EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH). This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 22, 1991, 32 days after receiving the submission on June 20, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K912729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1991 |
| Decision Date | July 22, 1991 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |