Jas Diagnostics, Inc.
Medical device manufacturer in Miami Lakes, FL.
20510(k) clearances
0PMA approvals
3recalls
Device types
- CIG Diazo Colorimetry, Bilirubin 2
- KHS Enzymatic, Carbon-Dioxide 1
- JJE Analyzer, Chemistry (Photometric… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- LCP Assay, Glycosylated Hemoglobin 1
- JHM Colorimetric Method, Lipoproteins 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- JIT Calibrator, Secondary 1
- JFJ Catalytic Methods, Amylase 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- CFR Hexokinase, Glucose 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CJY Azo Dye, Calcium 1
- JGJ Photometric Method, Magnesium 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | 05/15/2014SE |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | 11/17/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | 05/23/2008SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
| K021671 | Jas HDL Cholesterol (Automated) ReagentLBS · Traditional | 07/19/2002SE |
| K020454 | Chemistry CalibratorJIT · Traditional | 04/08/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | 12/21/2001SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | 09/06/2001SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | 08/21/2001SE |
| K011900 | Glucose (Hexokinase)CFR · Traditional | 07/31/2001SE |
| K011599 | Alkaline Phosphatase Liquid ReagentCJE · Traditional | 07/20/2001SE |
| K011441 | Jas Calcium (Arsenazo) ReagentCJY · Traditional | 07/09/2001SE |
| K003835 | Jas Magnesium ReagentJGJ · Traditional | 03/23/2001SE |
| K003912 | Phosphorus ReagentCEO · Traditional | 02/21/2001SE |
| K003829 | Total BilirubinCIG · Traditional | 02/12/2001SE |
| K003693 | Direct BilirubinCIG · Traditional | 01/29/2001SE |
| K003247 | CreatinineCGX · Traditional | 12/14/2000SE |
| K003327 | AlbuminCIX · Traditional | 12/05/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2656-2017 Class II | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner…May result in elevated platelet backgrounds during routine startup/background checks. | 04/21/2017Terminated |
| Z-0827-2015 Class II | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of…Product is not performing according to specifications. Control 2 does not consistently recover within its… | 10/23/2014Terminated |
| Z-1873-2014 Class II | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose…JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots… | 04/07/2014Terminated |