Medical Device Manufacturer · US , Miami , FL

Jas Diagnostics, Inc.

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

Jas Diagnostics, Inc. — FDA 510(k) Submissions

Jas Diagnostics, Inc. has submitted 20 FDA 510(k) premarket notifications since 2000, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Diazo Colorimetry, Bilirubin, Phosphomolybdate (colorimetric), Inorganic Phosphorus, Colorimetric Method, Lipoproteins, Azo Dye, Calcium, Assay, Glycosylated Hemoglobin . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · JJE Analyzer, Chemistry... · Chemistry
May 2014 408d
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
K080623 · CHH Enzymatic... · Chemistry
Nov 2008 257d
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · LCP Assay, Glycosylated... · Chemistry
May 2008 79d
LDL CHOLESTEROL (AUTOMATED)
K022519 · JHM Colorimetric Method,... · Chemistry
Sep 2002 62d
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · LBS Ldl & Vldl Precipitation,... · Chemistry
Jul 2002 59d
CHEMISTRY CALIBRATOR
K020454 · JIT Calibrator, Secondary · Chemistry
Apr 2002 56d
JAS AMYLASE LIQUID REAGENT
K020282 · JFJ Catalytic Methods, Amylase · Chemistry
Feb 2002 31d
CREATINE KINASE (CK-NAC)
K013912 · CGS Nad Reduction/nadh... · Chemistry
Jan 2002 52d
AST (SGOT)
K013698 · CIT Nadh Oxidation/nad... · Chemistry
Dec 2001 44d
JAS CARBON DIOXIDE LIQUID REAGENT
K012332 · KHS Enzymatic, Carbon-dioxide · Chemistry
Sep 2001 45d
JAS URIC ACID LIQUID REAGENT
K012038 · KNK Acid, Uric, Uricase... · Chemistry
Aug 2001 53d
GLUCOSE (HEXOKINASE)
K011900 · CFR Hexokinase, Glucose · Chemistry
Jul 2001 43d
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE Nitrophenylphosphate,... · Chemistry
Jul 2001 57d
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY Azo Dye, Calcium · Chemistry
Jul 2001 60d
JAS MAGNESIUM REAGENT
K003835 · JGJ Photometric Method,... · Chemistry
Mar 2001 101d
PHOSPHORUS REAGENT
K003912 · CEO Phosphomolybdate... · Chemistry
Feb 2001 64d
TOTAL BILIRUBIN
K003829 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Feb 2001 63d
DIRECT BILIRUBIN
K003693 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jan 2001 60d
CREATININE
K003247 · CGX Alkaline Picrate,... · Chemistry
Dec 2000 58d
ALBUMIN
K003327 · CIX Bromcresol Green... · Chemistry
Dec 2000 42d
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