K073488 is an FDA 510(k) clearance for the DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X. This device is classified as a Apolipoproteins (Class I - General Controls, product code MSJ).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on March 7, 2008, 137 days after receiving the submission on October 22, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K073488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2007 |
| Decision Date | March 07, 2008 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MSJ — Apolipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |