K965157 is an FDA 510(k) clearance for the CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1997, 25 days after receiving the submission on December 23, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K965157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1996 |
| Decision Date | January 17, 1997 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |