Submission Details
| 510(k) Number | K062128 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 2006 |
| Decision Date | August 21, 2006 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
Aug 2006
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K062128 is an FDA 510(k) clearance for the THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS, a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 21, 2006, 26 days after receiving the submission on July 26, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.
Device Classification
| Product Code | JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1215 |
Manufacturer
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