FDA 510(k) Applications Submitted by Jeffrey Dahlen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191364 |
05/22/2019 |
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 |
Fujimori Kogyo Co., Ltd. |
| K051787 |
07/01/2005 |
TRIAGE BNP TEST, MODEL 98000XR |
BIOSITE INCORPORATED |
| K050037 |
01/07/2005 |
TRIAGE TOX DRUG SCREEN CONTROLS |
BIOSITE INCORPORATED |
| K030088 |
01/10/2003 |
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS |
BIOSITE INCORPORATED |
| K030089 |
01/10/2003 |
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS |
BIOSITE INCORPORATED |
| K030286 |
01/28/2003 |
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL |
BIOSITE INCORPORATED |
| K010266 |
01/29/2001 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 |
BIOSITE INCORPORATED |
| K040437 |
02/19/2004 |
TRIAGE PROFILER S.O.B. PANEL |
BIOSITE INCORPORATED |
| K040459 |
02/23/2004 |
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS |
BIOSITE INCORPORATED |
| K032235 |
07/21/2003 |
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
BIOSITE INCORPORATED |
| K012745 |
08/16/2001 |
TRIAGE TOX DRUG SCREEN, CATALOG #94000 |
BIOSITE INCORPORATED |
| K012999 |
09/06/2001 |
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 |
BIOSITE INCORPORATED |
| K013002 |
09/06/2001 |
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 |
BIOSITE INCORPORATED |
| K043242 |
11/23/2004 |
TRIAGE TOX DRUG SCREEN |
BIOSITE INCORPORATED |
| K014247 |
12/26/2001 |
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 |
BIOSITE INCORPORATED |
| K033383 |
10/23/2003 |
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 |
BIOSITE INCORPORATED |
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