FDA 510(k) Applications Submitted by David Johnston
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960035 |
01/03/1996 |
CARBON DIOXIDE - DST |
TRACE AMERICA, INC. |
| K980026 |
01/05/1998 |
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K980028 |
01/05/1998 |
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K980030 |
01/05/1998 |
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K020454 |
02/11/2002 |
CHEMISTRY CALIBRATOR |
JAS Diagnostics, Inc. |
| K961114 |
03/20/1996 |
AST INCORPORATING DST |
TRACE SCIENTIFIC LTD. |
| K961123 |
03/21/1996 |
ALT INCORPORATING DST |
TRACE SCIENTIFIC LTD. |
| K961477 |
04/18/1996 |
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY |
TRACE AMERICA, INC. |
| K971477 |
04/23/1997 |
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
TRACE AMERICA, INC. |
| K011441 |
05/10/2001 |
JAS CALCIUM (ARSENAZO) REAGENT |
JAS Diagnostics, Inc. |
| K961984 |
05/21/1996 |
PORPHOBILINOGEN (PBG) |
TRACE AMERICA, INC. |
| K021671 |
05/21/2002 |
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
JAS Diagnostics, Inc. |
| K011596 |
05/24/2001 |
UREA NITROGEN (BUN) LIQUID REAGENT |
JAS DIAGNOSTIC, INC. |
| K011599 |
05/24/2001 |
ALKALINE PHOSPHATASE LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K982121 |
06/16/1998 |
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT |
TRACE SCIENTIFIC LTD. |
| K011900 |
06/18/2001 |
GLUCOSE (HEXOKINASE) |
JAS Diagnostics, Inc. |
| K972297 |
06/19/1997 |
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
| K012038 |
06/29/2001 |
JAS URIC ACID LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K962723 |
07/15/1996 |
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
TRACE AMERICA, INC. |
| K012332 |
07/23/2001 |
JAS CARBON DIOXIDE LIQUID REAGENT |
JAS Diagnostics, Inc. |
| K962890 |
07/24/1996 |
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) |
TRACE SCIENTIFIC LTD. |
| K022519 |
07/30/2002 |
LDL CHOLESTEROL (AUTOMATED) |
JAS Diagnostics, Inc. |
| K953971 |
08/23/1995 |
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY |
TRACE AMERICA, INC. |
| K973869 |
09/24/1997 |
TRACE REAGENT LINE FOR THE COBAS MIRA |
TRACE AMERICA, 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. |
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