Submission Details
| 510(k) Number | K060264 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2006 |
| Decision Date | March 08, 2006 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
Mar 2006
Decision
35d
Days
Class 1
Risk
About This 510(k) Submission
K060264 is an FDA 510(k) clearance for the DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85), 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 March 8, 2006, 35 days after receiving the submission on February 1, 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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