FDA 510(k) Applications Submitted by JAS Diagnostics, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020282 |
01/28/2002 |
JAS AMYLASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K003693 |
11/30/2000 |
DIRECT BILIRUBIN |
JAS Diagnostics, Inc. |
| K020454 |
02/11/2002 |
CHEMISTRY CALIBRATOR |
JAS Diagnostics, Inc. |
| K011441 |
05/10/2001 |
JAS CALCIUM (ARSENAZO) REAGENT |
JAS Diagnostics, Inc. |
| K021671 |
05/21/2002 |
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
JAS Diagnostics, Inc. |
| K011599 |
05/24/2001 |
ALKALINE PHOSPHATASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K011900 |
06/18/2001 |
GLUCOSE (HEXOKINASE) |
JAS Diagnostics, Inc. |
| K012038 |
06/29/2001 |
JAS URIC ACID LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K012332 |
07/23/2001 |
JAS CARBON DIOXIDE LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K022519 |
07/30/2002 |
LDL CHOLESTEROL (AUTOMATED) |
JAS Diagnostics, Inc. |
| K003247 |
10/17/2000 |
CREATININE |
JAS Diagnostics, Inc. |
| K003327 |
10/24/2000 |
ALBUMIN |
JAS Diagnostics, Inc. |
| K013698 |
11/07/2001 |
AST (SGOT) |
JAS Diagnostics, Inc. |
| K013912 |
11/27/2001 |
CREATINE KINASE (CK-NAC) |
JAS Diagnostics, Inc. |
| K003829 |
12/11/2000 |
TOTAL BILIRUBIN |
JAS Diagnostics, Inc. |
| K003835 |
12/12/2000 |
JAS MAGNESIUM REAGENT |
JAS Diagnostics, Inc. |
| K003912 |
12/19/2000 |
PHOSPHORUS REAGENT |
JAS Diagnostics, Inc. |
| K130915 |
04/02/2013 |
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK |
JAS Diagnostics, Inc. |
| K080618 |
03/05/2008 |
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID |
JAS Diagnostics, Inc. |
| K080623 |
03/05/2008 |
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA |
JAS Diagnostics, Inc. |
|
|
