FDA 510(k) Applications for Medical Device Product Code "GIZ"
(Plasma, Control, Normal)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K961814 |
CARDIOVASCULAR DIAGNOSTICS, INC. |
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS |
08/13/1996 |
K023309 |
DADE BEHRING, INC. |
CONTROL PLASMA N |
11/01/2002 |
K001256 |
DADE BEHRING, INC. |
CONTROL PLASMA N |
05/24/2000 |
K042941 |
DADE BEHRING, INC. |
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS |
12/02/2004 |
K984129 |
PACIFIC HEMOSTASIS |
COAGULATION CONTROL LEVEL 1 (NORMAL) |
12/01/1998 |
K013708 |
PRECISION BIOLOGIC |
REFERENCE CHECK, CATALOG NUMBER-RCN-10 |
12/10/2001 |
K003328 |
SIGMA DIAGNOSTICS, INC. |
ACCUCLOT CONTROL I, MODEL A4089 |
03/01/2001 |
K973274 |
SIGMA DIAGNOSTICS, INC. |
ACCUCOLOR HIGH CALIBRATOR (A3089) |
10/31/1997 |
K060968 |
WORTHAM LABORATORIES INC |
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW |
05/15/2007 |
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