K013207 is an FDA 510(k) clearance for the TINA-QUANT APOLIPOPROTEIN B VER.2. This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 13, 2001, 49 days after receiving the submission on September 25, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K013207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2001 |
| Decision Date | November 13, 2001 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |