Atlas FDA

GIZ

20 FDA 510(k) clearances · Product code

45 daysmedian time to decision
403 days90th percentile
20clearances measured

FDA profile

Official device name
Plasma, Control, Normal
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Medical specialty
Hematology
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RecordFirmDate
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW (K060968)Wortham Laboratories, Inc.2007-05-15
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (K042941)Dade Behring, Inc.2004-12-02
CONTROL PLASMA N (K023309)Dade Behring, Inc.2002-11-01
REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708)Precision Biologic2001-12-10
ACCUCLOT CONTROL I, MODEL A4089 (K003328)Sigma Diagnostics, Inc.2001-03-01
CONTROL PLASMA N (K001256)Dade Behring, Inc.2000-05-24
COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129)Pacific Hemostasis1998-12-01
ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274)Sigma Diagnostics, Inc.1997-10-31
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814)Cardiovascular Diagnostics, Inc.1996-08-13
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254)American Diagnostica, Inc.1994-09-19
CONTROL PLASMA N (K924403)Behring Diagnostics, Inc.1994-02-22
COAGULATION REFERENCE PLASMA, NORMAL (K932145)American Diagnostic Corp.1993-10-18
UNICALIBRATOR KIT (K922021)American Bioproducts Co.1992-06-09
COAGULATION REFERENCE PLASMA, NORMAL (K905203)Medical Diagnostic Technologies, Inc.1990-12-28
NORMAL COAGULATION CONTROL PLASMA (NCCP) (K895262)Medical Diagnostic Technologies, Inc.1989-10-06
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I (K893784)Analytical Control Systems, Inc.1989-06-23
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I (K893783)Analytical Control Systems, Inc.1989-06-23
EDL NORMAL COAGULATION CONTROL (K891179)Elite Diagnostic , Ltd.1989-04-10
CLP NORMAL COAGULATION CONTROL (K880712)Creative Laboratory Products, Inc.1988-05-06

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Every clearance here is in the API, with alerts when new ones post.