The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Tacr Flex Reagent Cartridge, Model Df107.
Device ID | K060502 |
510k Number | K060502 |
Device Name: | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 |
Classification | Enzyme Immunoassay, Tracrolimus |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
Contact | Yuk-ting Lewis |
Correspondent | Yuk-ting Lewis DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
Product Code | MLM |
CFR Regulation Number | 862.1678 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-24 |
Decision Date | 2006-05-18 |
Summary: | summary |