JAS Diagnostics Inc.
FDA Regulatory Profile
JAS Diagnostics Inc. appears in FDA public data with 3 recalls, 20 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2656-2017, Class II) was initiated on April 21, 2017. Its most recent 510(k) clearance was granted on May 15, 2014.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2656-2017 | Class II | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL | April 21, 2017 |
| Z-0827-2015 | Class II | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in ser | October 23, 2014 |
| Z-1873-2014 | Class II | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. | April 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | May 15, 2014 |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | November 17, 2008 |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | May 23, 2008 |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | September 30, 2002 |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | July 19, 2002 |
| K020454 | CHEMISTRY CALIBRATOR | April 8, 2002 |
| K020282 | JAS AMYLASE LIQUID REAGENT | February 28, 2002 |
| K013912 | CREATINE KINASE (CK-NAC) | January 18, 2002 |
| K013698 | AST (SGOT) | December 21, 2001 |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | September 6, 2001 |
| K012038 | JAS URIC ACID LIQUID REAGENT | August 21, 2001 |
| K011900 | GLUCOSE (HEXOKINASE) | July 31, 2001 |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | July 20, 2001 |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | July 9, 2001 |
| K003835 | JAS MAGNESIUM REAGENT | March 23, 2001 |
| K003912 | PHOSPHORUS REAGENT | February 21, 2001 |
| K003829 | TOTAL BILIRUBIN | February 12, 2001 |
| K003693 | DIRECT BILIRUBIN | January 29, 2001 |
| K003247 | CREATININE | December 14, 2000 |
| K003327 | ALBUMIN | December 5, 2000 |