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Panels › Clinical Chemistry › Product code CDT · Class 1

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Regulation 862.1705

0510(k)s in 12 months (151 all time)
0recalls in 12 months (20 all time)
13recalls that name a 510(k)
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Top companies in CDT

Decided510(k)Device and applicantCode
Jan 21, 1988K874584TRIGLYERIDES TEST KIT
Ciba Corning Diagnostics Corp.
CDT
Jan 21, 1988K874187A-GENT TRIGLLYCERIDES GPO
Abbott Laboratories
CDT
Sep 8, 1987K873160BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
Biotrol, USA, Inc.
CDT
Aug 28, 1987K873049TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
Boehringer Mannheim Corp.
CDT
May 8, 1987K871509RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
Trace Scientific , Ltd., AU
CDT
May 8, 1987K871508RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
Trace Scientific , Ltd., AU
CDT
Apr 22, 1987K871301ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
American Monitor Corp.
CDT
Apr 7, 1987K871122TRIGLYCERIDES DETERMINATION
Biochemical Trade, Inc.
CDT
Mar 13, 1987K870827INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
Intersect Systems, Inc.
CDT
Mar 4, 1987K870408EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
Em Diagnostic Systems, Inc.
CDT
Feb 20, 1987K870012TRIGLYCERIDE (GPO-TRINDER) REAGENT
Sigma Diagnostics, Inc.
CDT
Dec 31, 1986K864939BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
Beckman Instruments, Inc.
CDT
Dec 16, 1986K864268IQ TRIGLYCERIDES
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDT
Dec 4, 1986K864231U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
U. S. Diagnostics, Inc.
CDT
Nov 24, 1986K863923TRIGLYCERIDES
Tech-Co, Inc.
CDT
Nov 13, 1986K863874LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES
Electro-Nucleonics Laboratories, Inc.
CDT
Sep 26, 1986K863254TRIGLYCERIDE (TRINDER) PROCEDURE
Data Medical Associates, Inc.
CDT
Sep 26, 1986K863075TRIGLYCERIDES-E
J. D. Assoc.
CDT
Aug 19, 1986K862706EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
Em Diagnostic Systems, Inc.
CDT
Jul 22, 1986K862033TRIGLYCERIDES
Pointe Scientific, Inc.,
CDT
Jul 1, 1986K861670TRIGLYCERIDE (TRINDER) PROCEDURE
Data Medical Associates, Inc.
CDT
Jun 27, 1986K861793TWIN TRIGLYCERIDES GPO/CHOLESTEROL
Boehringer Mannheim Corp.
CDT
Jun 27, 1986K861635TRIGLYCERIDES GPO-TRINDER
Catachem, Inc.
CDT
Apr 7, 1986K860730ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
Trace Scientific , Ltd., AU
CDT
Mar 17, 1986K860690TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
Catachem, Inc.
CDT
Feb 19, 1986K855164ENZYNATIC TRIGLYCERIDES REAGENT SET
Sterling Diagnostics, Inc.
CDT
Jan 22, 1986K854783TRIGLYCERIDE'S TEST (TRIGLI-CINET)
Sclavo, Inc.
CDT
Nov 25, 1985K854366ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
American Monitor Corp.
CDT
Nov 25, 1985K854182IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
Clinical Data, Inc.
CDT
Nov 5, 1985K854152TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
Technicon Instruments Corp.
CDT
May 30, 1985K852010TGL REAGENT
Alpkem Corp.
CDT
May 20, 1985K851538TRIGLYCERIDE(TRINDER) PROCEDURE
Data Medical Associates, Inc.
CDT
Mar 11, 1985K850667PERIDOCHROM TRIGLYCERIDES GPO
Boehringer Mannheim Corp.
CDT
Feb 4, 1985K850031VISION TRIGLYCERIDES
Abbott Laboratories
CDT
Nov 27, 1984K843832TRIGLYCERIDES REAGENT SYSTEM
Fermco Biochemics, Inc.
CDT
Nov 9, 1984K844032TRIGLYCERIDE REAGENT
Sigma Diagnostics, Inc.
CDT
Oct 11, 1984K843536TRIGLYCERIDE ASSAY KIT GPO-CP
Diagnostic Chemicals, Ltd. (Usa)
CDT
Sep 26, 1984K843552TRIGLYCERIDES GPO REAGENT
Bio-Rad
CDT
Sep 13, 1984K842443AXIOM STABLE II TRIGLYCERIDES TEST
Axiom, Inc.
CDT
Aug 27, 1984K843106SYSTEMATE TRIGLYCERIDE 67219
Em Diagnostic Systems, Inc.
CDT
Aug 22, 1984K842891QCA TRIGLYCERIDES
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDT
Jul 9, 1984K842029TRIGLYCERIDES-GPO REAGENT
Reagents Applications, Inc.
CDT
Jul 6, 1984K842211ULTRA CHEM ENZYMATIC TRIGLYCERIDE
Em Diagnostic Systems, Inc.
CDT
May 16, 1984K841471ULTRA CHEM ENZYMATIC TRIGLYCERIDE
Em Diagnostic Systems, Inc.
CDT
May 1, 1984K841062TRIGLYCERIDE REAGENT SET
Medical Specialties, Inc.
CDT
Apr 5, 1984K840780TRIGLYCERIDES REAGENT
American Dade
CDT
Mar 2, 1984K834518LIQUID STABLE TRIGLYCERIDES REAGENT SET
Medical Analysis Systems, Inc.
CDT
Nov 25, 1983K833082REAGENT SET TRIGLYCERIDES GPO
Boehringer Mannheim Corp.
CDT
Oct 14, 1983K832871LIPASE HYDROLYSIS/GLYCEROL KINASE
Pointe Scientific, Inc.,
CDT
Oct 4, 1983K832684SERALYZER TRIGLYCERIDES REAGENT STRIPS
Miles Laboratories, Inc.
CDT

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