Medical Device Manufacturer · US , Miami , FL

Jas Diagnostics, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2000
20
Total
20
Cleared
0
Denied

Jas Diagnostics, Inc. — FDA 510(k) Products and Clearance History Chemistry

20 devices
1-20 of 20
Cleared May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · JJE
Chemistry · 408d
Cleared Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
K080623 · CHH
Chemistry · 257d
Cleared May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · LCP
Chemistry · 79d
Cleared Sep 30, 2002
LDL CHOLESTEROL (AUTOMATED)
K022519 · JHM
Chemistry · 62d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · LBS
Chemistry · 59d
Cleared Apr 08, 2002
CHEMISTRY CALIBRATOR
K020454 · JIT
Chemistry · 56d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282 · JFJ
Chemistry · 31d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · CGS
Chemistry · 52d
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Chemistry · 44d
Cleared Sep 06, 2001
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS
Chemistry · 45d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038 · KNK
Chemistry · 53d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Chemistry · 43d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE
Chemistry · 57d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY
Chemistry · 60d
Cleared Mar 23, 2001
JAS MAGNESIUM REAGENT
K003835 · JGJ
Chemistry · 101d
Cleared Feb 21, 2001
PHOSPHORUS REAGENT
K003912 · CEO
Chemistry · 64d
Cleared Feb 12, 2001
TOTAL BILIRUBIN
K003829 · CIG
Chemistry · 63d
Cleared Jan 29, 2001
DIRECT BILIRUBIN
K003693 · CIG
Chemistry · 60d
Cleared Dec 14, 2000
CREATININE
K003247 · CGX
Chemistry · 58d
Cleared Dec 05, 2000
ALBUMIN
K003327 · CIX
Chemistry · 42d
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