K963191 is an FDA 510(k) clearance for the CEDIA ANTIBIOTIC TDM MULTI-CALS. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on September 10, 1996, 26 days after receiving the submission on August 15, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K963191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1996 |
| Decision Date | September 10, 1996 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |