Jas Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK, CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA, DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jas Diagnostics, Inc. Chemistry ✕
20 devices
Cleared
May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
Chemistry
408d
Cleared
Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
Chemistry
257d
Cleared
May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
Chemistry
79d
Cleared
Sep 30, 2002
LDL CHOLESTEROL (AUTOMATED)
Chemistry
62d
Cleared
Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
Chemistry
59d
Cleared
Apr 08, 2002
CHEMISTRY CALIBRATOR
Chemistry
56d
Cleared
Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
Chemistry
31d
Cleared
Jan 18, 2002
CREATINE KINASE (CK-NAC)
Chemistry
52d
Cleared
Dec 21, 2001
AST (SGOT)
Chemistry
44d
Cleared
Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
Chemistry
45d
Cleared
Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
Chemistry
53d
Cleared
Jul 31, 2001
GLUCOSE (HEXOKINASE)
Chemistry
43d