ClearanceBrief
Panels › Clinical Chemistry › Product code JHM · Class 1

Colorimetric Method, Lipoproteins

Regulation 862.1475

0510(k)s in 12 months (9 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in JHM

Decided510(k)Device and applicantCode
Apr 24, 2012K120662PICCOLO HDL-CAPILLARY TEST SYSTEM
Abaxis, Inc.
JHM
Jul 2, 2008K081300DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
Siemens Healthcare Diagnostics
JHM
Feb 21, 2008K073072DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
Dade Behring, Inc.
JHM
Oct 30, 2003K032798DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
Dade Behring, Inc.
JHM
Sep 30, 2002K022519LDL CHOLESTEROL (AUTOMATED)
Jas Diagnostics, Inc.
JHM
Jan 11, 1999K983849DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
JHM
Sep 27, 1990K902935ROCHE COBAS READY HDL CHOLESTEROL REAGENT
Roche Diagnostic Systems, Inc.
JHM
May 1, 1984K841056HDL PRECIPITANT REAGENT SET
Medical Specialties, Inc.
JHM
May 3, 1978K780173LYPOPROTEIN CHOLESTEROL TEST KIT
Environmental Chemical Specialties
JHM

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