JHM · Class I · 21 CFR 862.1475

FDA Product Code JHM: Colorimetric Method, Lipoproteins

Leading manufacturers include Dade Behring, Inc. and Roche Diagnostic Systems, Inc..

9
Total
9
Cleared
70d
Avg days
1978
Since

FDA 510(k) Cleared Colorimetric Method, Lipoproteins Devices (Product Code JHM)

9 devices
1–9 of 9
Cleared Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072
Dade Behring, Inc.
Chemistry · 113d
Cleared Oct 30, 2003
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
K032798
Dade Behring, Inc.
Chemistry · 51d
Cleared Jan 11, 1999
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
K983849
Dade Behring, Inc.
Chemistry · 73d
Cleared Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935
Roche Diagnostic Systems, Inc.
Chemistry · 86d

About Product Code JHM - Regulatory Context