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 |