The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Automated High Density Lipoprotein Cholesterol (adhl) Flex Reagent Cartridge.
| Device ID | K983849 |
| 510k Number | K983849 |
| Device Name: | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE |
| Classification | Colorimetric Method, Lipoproteins |
| Applicant | DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 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 | 1998-10-30 |
| Decision Date | 1999-01-11 |
| Summary: | summary |