Submission Details
| 510(k) Number | K053104 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 2005 |
| Decision Date | December 23, 2005 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
Dec 2005
Decision
49d
Days
Class 2
Risk
About This 510(k) Submission
K053104 is an FDA 510(k) clearance for the DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 23, 2005, 49 days after receiving the submission on November 4, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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