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Instrument, Coagulation, Automated

FDA product code GKP · 48 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5400
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1982-01-28 – 2024-08-16

GKP 2024-08-16

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

Applicant Instrumentation Laboratory (IL) Co.

K number K242127

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GKP 2023-06-21

ACL TOP Family 70 Series

Applicant Instrumentation Laboratory Company

K number K231031

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GKP 2016-03-03

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

Applicant Instrumentation Laboratory CO

K number K160276

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GKP 2009-09-22

ACL TOP 700 LAS

Applicant Instrumentation Laboratory CO

K number K091980

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GKP 2008-05-04

ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

Applicant Instrumentation Laboratory CO

K number K073377

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GKP 2007-01-12

ACL TOP

Applicant Instrumentation Laboratory CO

K number K063679

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GKP 2004-01-12

ACL TOP MODEL, TOP

Applicant Instrumentation Laboratory CO

K number K033414

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GKP 2003-09-08

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

Applicant Dade Behring, Inc.

K number K031377

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GKP 2002-12-09

FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN

Applicant Fisher Diagnostics

K number K023362

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GKP 2002-06-27

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

Applicant Dade Behring, Inc.

K number K020979

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GKP 2000-08-04

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

Applicant Dade Behring, Inc.

K number K001645

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GKP 2000-07-12

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C

Applicant Bio/Data Corp.

K number K001891

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GKP 2000-05-11

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

Applicant Dade Behring, Inc.

K number K001145

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GKP 1999-12-07

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

Applicant Dade Behring, Inc.

K number K993299

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GKP 1999-11-09

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

Applicant Dade Behring, Inc.

K number K993174

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GKP 1999-09-21

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

Applicant Dade Behring, Inc.

K number K992763

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GKP 1999-09-21

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500

Applicant Dade Behring, Inc.

K number K992423

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GKP 1999-09-17

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

Applicant Dade Behring, Inc.

K number K992321

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GKP 1999-06-01

COAG-A-MATE MAX

Applicant Organon Teknika Corp.

K number K991101

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GKP 1998-05-26

TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)

Applicant Cardiovascular Diagnostics, Inc.

K number K981206

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GKP 1997-02-06

SYSMEX CA-6000

Applicant Dade Intl., Inc.

K number K964139

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GKP 1997-01-22

COAG-A-MATE MTX

Applicant Organon Teknika Corp.

K number K962857

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GKP 1996-09-10

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER

Applicant Medical Laboratory Automation Systems, Inc.

K number K962664

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GKP 1996-09-04

ACL 6000 SYSTEM (ACL 6000)

Applicant Instrumentation Laboratory CO

K number K961991

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GKP 1996-07-10

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant American Bioproducts Co.

K number K961579

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GKP 1996-01-30

THROMBELASTOGRAPH COAGULATION ANALYZER 3000S

Applicant Haemoscope Corp.

K number K954437

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GKP 1995-10-27

PROTIME MICROCOAGULATION SYSTEM

Applicant International Technidyne Corp.

K number K951072

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GKP 1995-03-24

MICROSAMPLE COAGULATION ANALYZER

Applicant Bio/Data Corp.

K number K943153

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GKP 1995-02-03

ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER

Applicant Medical Laboratory Automation Systems, Inc.

K number K944227

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GKP 1995-02-01

STA AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant American Bioproducts Co.

K number K942117

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GKP 1994-12-22

HEMOLAB

Applicant Biomerieux Vitek, Inc.

K number K931992

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GKP 1993-11-15

TAS ANALYZER

Applicant Cardiovascular Diagnostic Services

K number K933092

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GKP 1993-08-23

CASCADE M, CAT. NO. 1710

Applicant Helena Laboratories

K number K931956

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GKP 1993-08-23

ELECTRA 1600C AUTOMATIC COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K931206

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GKP 1993-06-18

IL MCL-2 COAGULATION ANALYZER

Applicant Instrumentation Laboratory CO

K number K924098

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GKP 1992-06-29

CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)

Applicant Helena Laboratories

K number K921465

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GKP 1992-06-09

CASCADE 480

Applicant Helena Laboratories

K number K921363

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GKP 1992-01-13

CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION

Applicant Helena Laboratories

K number K914946

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GKP 1990-11-13

ST-4 COAGULATION INSTRUMENT

Applicant American Bioproducts Co.

K number K904297

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GKP 1990-11-01

THROMBELASTOGRAPH

Applicant Haemoscope Corp.

K number K904204

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GKP 1990-05-25

CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430

Applicant Helena Laboratories

K number K901380

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GKP 1990-05-22

KOAGULAB 60-S COAGULATION SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K901120

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GKP 1989-10-24

THROMBELASTOGRAPH(R)

Applicant Haemoscope Corp.

K number K895844

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GKP 1989-07-27

ELECTRA 1000C AUTOMATIC COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K894052

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GKP 1989-02-03

KOAGULAB* 32-S COAGULATION SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K885035

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GKP 1989-02-03

ELECTRA 900C AUTOMATIC COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K884863

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GKP 1988-05-18

COAG-A-MATE(R) XM

Applicant Organon Teknika Corp.

K number K881281

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GKP 1982-01-28

COAG-A-MATE X2

Applicant General Diagnostics

K number K813564

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