The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Automated Hdl Cholesterol (ahdl) Flex Reagent Cartridge (df48a) Catalog # Df48a.
Device ID | K032798 |
510k Number | K032798 |
Device Name: | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A |
Classification | Colorimetric Method, Lipoproteins |
Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
Contact | Andrea M Tasker |
Correspondent | Andrea M Tasker DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
Product Code | JHM |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-09 |
Decision Date | 2003-10-30 |
Summary: | summary |