CDT · Class I · 21 CFR 862.1705

FDA Product Code CDT: Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

Leading manufacturers include Em Diagnostic Systems, Inc., Data Medical Associates, Inc. and Boehringer Mannheim Corp..

151
Total
151
Cleared
62d
Avg days
1976
Since
151 devices
97–120 of 151
Cleared Mar 02, 1984
LIQUID STABLE TRIGLYCERIDES REAGENT SET
K834518
Medical Analysis Systems, Inc.
Chemistry · 72d
Cleared Nov 25, 1983
REAGENT SET TRIGLYCERIDES GPO
K833082
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Oct 14, 1983
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Sep 12, 1983
EASYTOUCH TRIGLYCERIDES REAGENT SET
K832426
Worthington Diagnostic Systems
Chemistry · 52d
Cleared Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444
Stanbio Laboratory
Chemistry · 37d
Cleared Jul 22, 1983
TRIGLYCERIDES REAGENT SET
K831858
Stanbio Laboratory
Chemistry · 42d
Cleared Feb 25, 1983
TRIGLYCERIDE DIAGNOSTIC KIT
K830288
Sclavo, Inc.
Chemistry · 29d
Cleared Jan 07, 1983
TRIGLYCERIDE REAGENT (UV)
K823709
Gilford Diagnostics
Chemistry · 29d
Cleared Dec 22, 1982
TRIGLYCERIDES REAGENT SET TAG-GK
K823341
Sterling Biochemical, Inc.
Chemistry · 44d
Cleared Jul 20, 1982
TRIGLYCERIDE REAGENT SET
K821205
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875
Harleco Diagnostics
Chemistry · 18d
Cleared May 24, 1982
DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
K821315
The Dow Chemical Co.
Chemistry · 20d
Cleared Dec 03, 1981
TRIGLYCERIDE REAGENT SET
K812838
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Sep 24, 1981
ULTRA CHEM E-TRIG #65024
K812589
Harleco
Chemistry · 13d
Cleared Sep 14, 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029
Eastman Kodak Company
Chemistry · 14d
Cleared Jul 23, 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850
Smithkline Diagnostics, Inc.
Chemistry · 22d
Cleared Apr 17, 1981
DATA-ZYME TRIGLYCERIDE
K810965
Data Medical Associates, Inc.
Chemistry · 9d
Cleared Mar 31, 1981
ENZYMATIC TRIGLYCERIDE
K810680
Pointe Scientific, Inc.,
Chemistry · 18d
Cleared Jan 16, 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297
Amresco, Inc.
Chemistry · 17d
Cleared Jan 09, 1981
TRIGLYCERIDES (UV)-2 REAGENTS
K803091
Reagents Applications, Inc.
Chemistry · 32d
Cleared Oct 23, 1980
TRIGLYCERIDES DETERMINATION
K802256
Coleman Laboratories Corp.
Chemistry · 37d
Cleared Oct 10, 1980
DELTA TEST TRIGLYCERIDES
K802136
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 36d