JGY · Class I · 21 CFR 862.1705

FDA Product Code JGY: Colorimetric Method, Triglycerides

Leading manufacturers include Data Medical Associates, Inc., Dade, Baxter Travenol Diagnostics, Inc. and Volu Sol Medical Industries.

22
Total
22
Cleared
79d
Avg days
1977
Since

FDA 510(k) Cleared Colorimetric Method, Triglycerides Devices (Product Code JGY)

22 devices
1–22 of 22
Cleared Jul 20, 1994
DNA TRIGLYCERIDE PROCEDURE
K941063
Data Medical Associates, Inc.
Chemistry · 134d
Cleared Mar 28, 1994
IL TEST(TM) TRIGLYCERIDE
K931116
Instrumentation Laboratory CO
Toxicology · 389d
Cleared Jul 31, 1990
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202
Data Medical Associates, Inc.
Chemistry · 76d
Cleared Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063
Sigma Diagnostics, Inc.
Chemistry · 91d
Cleared Feb 10, 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Apr 07, 1986
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731
Trace Scientific , Ltd.
Chemistry · 40d
Cleared May 05, 1982
TRIGLYZYME V EIKEN
K821106
Syn-Kit, Inc.
Chemistry · 15d
Cleared May 14, 1980
TRIGLYCERIDE REAGENT (COLOR)
K801012
Gilford Diagnostics
Chemistry · 16d
Cleared Mar 25, 1980
TRIGLYCERIDES TEST (500NM)
K800551
Reagents Applications, Inc.
Chemistry · 15d
Cleared Dec 07, 1979
ELVI TRIGLYCERIDE
K792414
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 24, 1977
TRI-CON TRIGLYCERIDGE REAGENTS
K761283
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 66d

About Product Code JGY - Regulatory Context