Plasma, Control, Normal
Hematology · 21 CFR 864.5425
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
23 firms currently registered for this product code
Precision Biologic Inc.
Dartmouth Nova Scotia, CA
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Pentapharm Ag
Aesch Basel-Landschaft, CH
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
R2 Diagnostics, Inc.
SOUTH BEND, IN, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Helena Laboratories, Corp.
BEAUMONT, TX, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Biomedica Diagnostics Inc.
Windsor Nova Scotia, CA
Corgenix, Inc.
BROOMFIELD, CO, US
George King Bio-medical, Inc.
OVERLAND PARK, KS, US
Sts Corporation
Duluth, GA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
High Technology, Inc.
North Attleboro, MA, US
510(k) clearances
20 clearances for this product code
- Wortham Laboratories, Inc.May 15, 2007
K060968 · STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
- Dade Behring, Inc.Dec 2, 2004
K042941 · DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
- Dade Behring, Inc.Nov 1, 2002
K023309 · CONTROL PLASMA N
- Precision BiologicDec 10, 2001
K013708 · REFERENCE CHECK, CATALOG NUMBER-RCN-10
- Sigma Diagnostics, Inc.Mar 1, 2001
K003328 · ACCUCLOT CONTROL I, MODEL A4089
- Dade Behring, Inc.May 24, 2000
K001256 · CONTROL PLASMA N
- Pacific HemostasisDec 1, 1998
K984129 · COAGULATION CONTROL LEVEL 1 (NORMAL)
- Sigma Diagnostics, Inc.Oct 31, 1997
K973274 · ACCUCOLOR HIGH CALIBRATOR (A3089)