K013278 is an FDA 510(k) clearance for the TINA-QUANT APOLIPOPROTEIN A-1 VER.2. This device is classified as a Lipoprotein X, Antigen, Antiserum, Control (Class I - General Controls, product code DEL).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 15, 2001, 45 days after receiving the submission on October 1, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5590.
| 510(k) Number | K013278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2001 |
| Decision Date | November 15, 2001 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DEL — Lipoprotein X, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5590 |