Submission Details
| 510(k) Number | K060266 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2006 |
| Decision Date | March 09, 2006 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION IRON CALIBRATOR
Mar 2006
Decision
36d
Days
Class 2
Risk
About This 510(k) Submission
K060266 is an FDA 510(k) clearance for the DIMENSION IRON 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 March 9, 2006, 36 days after receiving the submission on February 1, 2006. 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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