K043546 is an FDA 510(k) clearance for the DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE. This device is classified as a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I - General Controls, product code CDT).
Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 18, 2005, 26 days after receiving the submission on December 23, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K043546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2004 |
| Decision Date | January 18, 2005 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |