Submission Details
| 510(k) Number | K032798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2003 |
| Decision Date | October 30, 2003 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
Oct 2003
Decision
51d
Days
Class 1
Risk
About This 510(k) Submission
K032798 is an FDA 510(k) clearance for the DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A, a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on October 30, 2003, 51 days after receiving the submission on September 9, 2003. 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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