Submission Details
| 510(k) Number | K983849 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
Jan 1999
Decision
73d
Days
Class 1
Risk
About This 510(k) Submission
K983849 is an FDA 510(k) clearance for the DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE, 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 January 11, 1999, 73 days after receiving the submission on October 30, 1998. 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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