K071146 is an FDA 510(k) clearance for the VIDAS B.R.A.H.M.S. PCT ASSAY. This device is classified as a Antigen, Inflammatory Response Marker, Sepsis (Class II - Special Controls, product code NTM).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 11, 2007, 170 days after receiving the submission on April 24, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3210. An Immunoluminometric Assay Used To Determine The Concentration Of Procalcitonin (pct) In Human Serum And Plasma..
| 510(k) Number | K071146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2007 |
| Decision Date | October 11, 2007 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NTM — Antigen, Inflammatory Response Marker, Sepsis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3210 |
| Definition | An Immunoluminometric Assay Used To Determine The Concentration Of Procalcitonin (pct) In Human Serum And Plasma. |