K081300 is an FDA 510(k) clearance for the DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE. This device is classified as a Colorimetric Method, Lipoproteins (Class I - General Controls, product code JHM).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on July 2, 2008, 55 days after receiving the submission on May 8, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K081300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2008 |
| Decision Date | July 02, 2008 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHM — Colorimetric Method, Lipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |