Submission Details
| 510(k) Number | K063608 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 04, 2006 |
| Decision Date | February 23, 2007 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
Feb 2007
Decision
81d
Days
Class 1
Risk
About This 510(k) Submission
K063608 is an FDA 510(k) clearance for the DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on February 23, 2007, 81 days after receiving the submission on December 4, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.
Device Classification
| Product Code | MSJ — Apolipoproteins |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |
Manufacturer
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