Submission Details
| 510(k) Number | K061251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2006 |
| Decision Date | May 31, 2006 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
May 2006
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K061251 is an FDA 510(k) clearance for the DIMENSION VISTA TOTAL IRON BINDING CAPACITY 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 May 31, 2006, 27 days after receiving the submission on May 4, 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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