K132174 is an FDA 510(k) clearance for the MULTICHEM WBT. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Techno-Path Manufacturing , Ltd. (Highland Village, US). The FDA issued a Cleared decision on September 20, 2013, 67 days after receiving the submission on July 15, 2013.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K132174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2013 |
| Decision Date | September 20, 2013 |
| Days to Decision | 67 days |
| Submission Type | Abbreviated |
| 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 |