Company ยท US
Jas Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2014. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFR | Hexokinase, Glucose | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| GKZ | Counter, Differential Cell | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JHM | Colorimetric Method, Lipoproteins | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2014 | K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK Jas Diagnostics, Inc. | JJE |
| Nov 17, 2008 | K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA Jas Diagnostics, Inc. | CHH |
| May 23, 2008 | K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID Jas Diagnostics, Inc. | LCP |
| Sep 30, 2002 | K022519 | LDL CHOLESTEROL (AUTOMATED) Jas Diagnostics, Inc. | JHM |
| Jul 19, 2002 | K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT Jas Diagnostics, Inc. | LBS |
| Apr 8, 2002 | K020454 | CHEMISTRY CALIBRATOR Jas Diagnostics, Inc. | JIT |
| Feb 28, 2002 | K020282 | JAS AMYLASE LIQUID REAGENT Jas Diagnostics, Inc. | JFJ |
| Jan 18, 2002 | K013912 | CREATINE KINASE (CK-NAC) Jas Diagnostics, Inc. | CGS |
| Dec 21, 2001 | K013698 | AST (SGOT) Jas Diagnostics, Inc. | CIT |
| Sep 6, 2001 | K012332 | JAS CARBON DIOXIDE LIQUID REAGENT Jas Diagnostics, Inc. | KHS |
| Aug 21, 2001 | K012038 | JAS URIC ACID LIQUID REAGENT Jas Diagnostics, Inc. | KNK |
| Jul 31, 2001 | K011900 | GLUCOSE (HEXOKINASE) Jas Diagnostics, Inc. | CFR |
| Jul 20, 2001 | K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT Jas Diagnostics, Inc. | CJE |
| Jul 9, 2001 | K011441 | JAS CALCIUM (ARSENAZO) REAGENT Jas Diagnostics, Inc. | CJY |
| Mar 23, 2001 | K003835 | JAS MAGNESIUM REAGENT Jas Diagnostics, Inc. | JGJ |
| Feb 21, 2001 | K003912 | PHOSPHORUS REAGENT Jas Diagnostics, Inc. | CEO |
| Feb 12, 2001 | K003829 | TOTAL BILIRUBIN Jas Diagnostics, Inc. | CIG |
| Jan 29, 2001 | K003693 | DIRECT BILIRUBIN Jas Diagnostics, Inc. | CIG |
| Dec 14, 2000 | K003247 | CREATININE Jas Diagnostics, Inc. | CGX |
| Dec 5, 2000 | K003327 | ALBUMIN Jas Diagnostics, Inc. | CIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2017 | JAS Diagnostics Inc. Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. Terminated |
GKZ | K071562 |
| Dec 18, 2014 | JAS Diagnostics Inc. Glucose Hexokinase (Liquid) Reagent
For the in vitro quantitative determination of Glucose in serum. Terminated |
CFR | K011900 |
| Jun 25, 2014 | JAS Diagnostics Inc. Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. Terminated |
CGA | K011900 |