Atlas FDA

GJT

79 FDA 510(k) clearances · Product code

66 daysmedian time to decision
340 days90th percentile
79clearances measured

FDA profile

Official device name
Plasma, Coagulation Factor Deficient
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
CRYOcheck Factor VIII Deficient Plasma with VWF (K222831)Precision Biologic, Inc.2023-09-13
HemosIL Factor XII Deficient Plasma (K180486)Instrumentation Laboratory CO2018-03-22
NOFACT IX (K102908)R2 Diagnostics, Inc.2011-12-19
NOFACT VIII (K102851)R2 Diagnostics, Inc.2011-12-19
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237)Instrumentation Laboratory CO2011-07-08
HEMOSIL FACTOR II DEFICIENT PLASMA (K050661)Instrumentation Laboratory CO2005-05-02
HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459)Instrumentation Laboratory CO2005-02-09
DIAPHARMA FACTOR X KIT (K040362)Diapharma Group, Inc.2004-07-12
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007)Instrumentation Laboratory CO2004-02-13
HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829)Instrumentation Laboratory CO2003-07-31
HEMOSIL FACTOR X DEFICIENT PLASMA (K031122)Instrumentation Laboratory CO2003-05-19
HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287)Instrumentation Laboratory CO2003-03-19
HEMOSIL FACTOR VII DEFICIENT PLASMA (K024082)Instrumentation Laboratory CO2003-02-12
HEMOSIL FACTOR V DEFICIENT PLASMA (K023839)Instrumentation Laboratory CO2003-01-14
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 (K990814)Precision Biologic1999-06-07
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) (K990296)Precision Biologic1999-03-18
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (K990046)Pacific Hemostasis1999-02-17
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) (K981174)Precision Biologicals, Inc.1999-01-13
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) (K981173)Precision Biologicals, Inc.1999-01-13
COAGULATION FACTOR V DEFICIENT PLASMA (K981709)Dade Behring, Inc.1998-10-13
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) (K972627)Pacific Hemostasis1997-08-13
CRYO CHECK FACTOR V DEFICIENT PLASMA (K971223)Precision Biologicals, Inc.1997-07-22
CRYO CHECK FACTOR X DEFICIENT PLASMA (K971227)Precision Biologicals, Inc.1997-07-18
CRYO CHECK FACTOR IX DEFICIENT PLASMA (K971226)Precision Biologicals, Inc.1997-07-18
CRYO CHECK FACTOR VIII DEFICIENT PLASMA (K971225)Precision Biologicals, Inc.1997-07-17
CRYO CHECK FACTOR VII DEFICIENT PLASMA (K971224)Precision Biologicals, Inc.1997-07-17
FACTOR DEFICIENT PLASMAS - FACTOR XI (11) (K972286)Universal Reagents, Inc.1997-07-14
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA (K970607)Universal Reagents, Inc.1997-04-25
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA (K970593)Universal Reagents, Inc.1997-04-25
STA - LIATEST VWF TEST KIT (K962675)American Bioproducts Co.1996-10-25
STA-VWF CALIBRATOR KIT (K962671)American Bioproducts Co.1996-09-13
PROTEIN C DEFICIENT PLASMA (K945857)George King Bio-Medical, Inc.1995-10-20
HEMOLAB COFAC IX (K942050)Biomerieux Vitek, Inc.1995-05-19
BIOMERIEUX HEMOLAB COFAC II (K942049)Biomerieux Vitek, Inc.1995-05-19
BIOMERIEUX HEMOLAB COFAC VII (K935850)Biomerieux Vitek, Inc.1995-01-17
BIOMERIEUX HEMOLAB COFAC X (K935851)Biomerieux Vitek, Inc.1995-01-17
FACTOR VIII DEFICIENT PLASMA (K935057)Sigma Diagnostics, Inc.1994-03-15
FACTOR VII DEFICIENT PLASMA (K935056)Sigma Diagnostics, Inc.1994-03-07
FACTOR (K935058)Sigma Diagnostics, Inc.1994-03-07
FACTOR X DEFICIENT PLASMA (K935054)Sigma Diagnostics, Inc.1994-03-07
STAGO FACTOR II-DEFICIENT PLASMA (K934606)American Bioproducts Co.1994-03-01
STAGO FACTOR V-DEFICIENT PLASMA (K934605)American Bioproducts Co.1994-03-01
STAGO FACTOR IX-DEFICIENT PLASMA (K933432)American Bioproducts Co.1993-11-15
STAGO FACTOR XI-DEFICIENT PLASMA (K933444)American Bioproducts Co.1993-10-27
STAGO FACTOR X-DEFICIENT PLASMA (K933441)American Bioproducts Co.1993-10-27
STAGO FACTOR XII-DEFICIENT PLASMA (K933438)American Bioproducts Co.1993-10-27
STAGO FACTOR VII-DEFICIENT PLASMA (K933440)American Bioproducts Co.1993-10-27
BIOMERIEUX HEMOLAB COFAC VIII (K933010)Biomerieux Vitek, Inc.1993-09-15
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA (K924400)Behring Diagnostics, Inc.1993-06-08
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA (K924396)Behring Diagnostics, Inc.1993-05-21
CLOTTING FACTOR V DEFICIENT PLASMA (K924394)Behring Diagnostics, Inc.1992-12-01
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA (K915411)Baxter Diagnostics, Inc.1992-05-11
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) (K912679)Baxter Healthcare Corp1991-09-10
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE (K902083)Helena Laboratories1990-06-15
ORTHO CORRECTION REAGENTS (K901327)Ortho Diagnostic Systems, Inc.1990-05-25
FACTOR V DEFICIENT PLASMA (K900406)Sigma Chemical Co.1990-03-06
FACTOR VII DEFICIENT PLASMA (K900407)Sigma Chemical Co.1990-03-06
FACTOR XII DEFICIENT PLASMA (K900412)Sigma Chemical Co.1990-03-06
FACTOR IX DEFICIENT PLASMA (K900409)Sigma Chemical Co.1990-03-06
FACTOR X DEFICIENT PLASMA (K900410)Sigma Chemical Co.1990-03-06
FACTOR II DEFICIENT PLASMA (K900906)Sigma Chemical Co.1990-03-06
FACTOR VIII DEFICIENT PLASMA (K900408)Sigma Chemical Co.1990-03-06
FACTOR XI DEFICIENT PLASMA (K900411)Sigma Chemical Co.1990-03-06
FACTOR II DEFICIENT PLASMA (K900133)Medical Diagnostic Technologies, Inc.1990-01-25
ABNORMAL REFERENCE PLASMA-VIII (K895503)Medical Diagnostic Technologies, Inc.1989-10-06
ABNORMAL REFERENCE PLASMA-IX (K895504)Medical Diagnostic Technologies, Inc.1989-10-06
FACTOR VIII DEFICIENT PLASMA (K893525)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR IX DEFICIENT PLASMA (K893524)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR VII DEFICIENT PLASMA (K893535)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR X DEFICIENT PLASMA (K893523)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR XII DEFICIENT PLASMA (K893534)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR XI DEFICIENT PLASMA (K893536)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR V DEFICIENT PLASMA (K893533)Medical Diagnostic Technologies, Inc.1989-06-23
ORTHO FACTOR XII DEFICIENT PLASMA (K883688)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR XI DEFICIENT PLASMA (K883691)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR X DEFICIENT PLASMA (K883690)Ortho Diagnostic Systems, Inc.1988-11-01
ORTHO FACTOR VII DEFICIENT PLASMA (K883692)Ortho Diagnostic Systems, Inc.1988-11-01
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN (K880874)Baxter Healthcare Corp1988-03-17
FACTOR VIII REFERENCE PLASMA (K880292)Helena Laboratories1988-02-19

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