Submission Details
| 510(k) Number | K061793 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2006 |
| Decision Date | August 07, 2006 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
Aug 2006
Decision
42d
Days
Class 1
Risk
About This 510(k) Submission
K061793 is an FDA 510(k) clearance for the DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 7, 2006, 42 days after receiving the submission on June 26, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.
Device Classification
| Product Code | JIY — Photometric Method, Iron (non-heme) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1410 |
Manufacturer
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