K961659 is an FDA 510(k) clearance for the CEDIA CORE TDM MULTI-CAL. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Boehringer Mannheim Corp. (Columbus, US). The FDA issued a Cleared decision on June 13, 1996, 44 days after receiving the submission on April 30, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K961659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1996 |
| Decision Date | June 13, 1996 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |