Submission Details
| 510(k) Number | K060502 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2006 |
| Decision Date | May 18, 2006 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
May 2006
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K060502 is an FDA 510(k) clearance for the DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 18, 2006, 83 days after receiving the submission on February 24, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.
Device Classification
| Product Code | MLM — Enzyme Immunoassay, Tracrolimus |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1678 |
Manufacturer
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