K061377 is an FDA 510(k) clearance for the APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS. This device is classified as a Apolipoproteins (Class I - General Controls, product code MSJ).
Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on March 28, 2007, 315 days after receiving the submission on May 17, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K061377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2006 |
| Decision Date | March 28, 2007 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MSJ — Apolipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |