Submission Details
| 510(k) Number | K072435 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2007 |
| Decision Date | October 17, 2007 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
Oct 2007
Decision
48d
Days
Class 2
Risk
About This 510(k) Submission
K072435 is an FDA 510(k) clearance for the DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on October 17, 2007, 48 days after receiving the submission on August 30, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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