Submission Details
| 510(k) Number | K073072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2007 |
| Decision Date | February 21, 2008 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
Feb 2008
Decision
113d
Days
Class 1
Risk
About This 510(k) Submission
K073072 is an FDA 510(k) clearance for the DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B, a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 21, 2008, 113 days after receiving the submission on October 31, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.
Device Classification
| Product Code | JHM — Colorimetric Method, Lipoproteins |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |
Manufacturer
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