Atlas FDA

GGC

40 FDA 510(k) clearances · Product code

55 daysmedian time to decision
336 days90th percentile
40clearances measured

FDA profile

Official device name
Control, Plasma, Abnormal
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Medical specialty
Hematology
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RecordFirmDate
HEMOSIL LA POSITIVE CONTROL (K102552)Instrumentation Laboratory CO2011-04-05
SPECIALTY ASSAYED CONTROL-2 (K100103)Helena Laboratories2010-12-15
PLASMACON N, PLASMACON L-1, PLASMACON L-2 (K062306)R2 Diagnostics, Inc.2007-03-16
STA - CONTROL LA 1+2 (K061803)Diagnostica Stago, Inc.2006-07-28
CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804)Precision Biologic2003-11-03
CONTROL PLASMA P (K023312)Dade Behring, Inc.2002-11-01
LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878)Bio-Rad2002-04-15
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109)Sigma Diagnostics, Inc.2002-02-06
K-ASSAY D-DIMER CONTROLS (K012422)Kamiya Biomedical Co.2001-08-21
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329)Sigma Diagnostics, Inc.2001-03-01
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332)Gradipore , Ltd.2000-02-16
COAGULATION CONTROL LEVEL 2 (ABNORMAL) (K984130)Pacific Hemostasis1998-12-01
COAGULATION CONTROL LEVEL 3 (ABNORMAL) (K984131)Pacific Hemostasis1998-12-01
LA POSITIVE CONTROL PLASMA (K961370)Medical Diagnostic Technologies, Inc.1996-05-24
AT-III CONTROL PLASMA KIT (K955040)American Bioproducts Co.1996-01-31
CRYO CHECK LUPUS PLASMA (K952623)Precision Biologicals, Inc.1995-11-06
CRYO CHECK ABNORMAL REFERENCE CHECK I & II (K952624)Precision Biologicals, Inc.1995-10-30
POSITIVE LUPUS ANTICOAGULANT PLASMA (K945856)George King Bio-Medical, Inc.1995-10-05
STA-COAG CONTROL [P] PLUS KIT (K952338)American Bioproducts Co.1995-09-21
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 (K941872)Helena Laboratories1994-11-21
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL (K930267)Biomerieux Vitek, Inc.1994-03-22
CONTROL PLASMA U (K924402)Behring Diagnostics, Inc.1994-02-22
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) (K924401)Behring Diagnostics, Inc.1994-02-22
FACTOR CONTROL [P] (K930959)American Bioproducts Co.1993-05-20
COAG-CONTROL (K930923)American Bioproducts Co.1993-04-27
CONTROL PLASMA P (K924405)Behring Diagnostics, Inc.1992-12-01
AVK CONTROL I & II (K921665)American Bioproducts Co.1992-06-09
DADE(R) PROTEIN C ABNORMAL CONTRAL (K911885)Baxter Healthcare Corp1991-06-11
COAGULATION REFERENCE PLASMA, ABNORMAL (K904073)Medi-Tech, Inc.1990-10-22
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA (K901233)Ortho Diagnostic Systems, Inc.1990-04-11
HEPARIN CONTROL PLASMA, FOR USE IN APTT (K900782)Medical Diagnostic Technologies, Inc.1990-03-27
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) (K895261)Medical Diagnostic Technologies, Inc.1989-10-06
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) (K895260)Medical Diagnostic Technologies, Inc.1989-10-06
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III (K894425)Analytical Control Systems, Inc.1989-08-03
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III (K894338)Analytical Control Systems, Inc.1989-07-25
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II (K893970)Analytical Control Systems, Inc.1989-07-25
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II (K893971)Analytical Control Systems, Inc.1989-07-25
CLP ABNORMAL COAGULATION CONTROL (K881510)Creative Laboratory Products, Inc.1988-05-06
HERPES 1 AND 2 MICROASSAYS (K871420)Diamedix Corp.1987-12-11
HPC TM (HEPARINIZED PLASMA CONTROL) (K770188)Bio/Data Corp.1977-02-18

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