Product Code: GKP FDA class 2 21 CFR 864.5400

Instrument, Coagulation, Automated

Hematology

Instrument, Coagulation, Automated (product code GKP) is a fully automated analyzer used in hematology laboratories to perform a range of coagulation assays, including prothrombin time, activated partial thromboplastin time, fibrinogen determination, and other clotting studies, with automated sample handling and endpoint detection. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5400 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GKP
Device Class: FDA class 2
Regulation Number: 864.5400
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242127	ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)	Aug 16, 2024	Substantially Equivalent	Instrumentation Laboratory (IL) Co.
K231031	ACL TOP Family 70 Series	Jun 21, 2023	Substantially Equivalent	Instrumentation Laboratory Company
K160276	ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)	Mar 03, 2016	Substantially Equivalent	Instrumentation Laboratory CO
K150877	ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS	Dec 13, 2015	Substantially Equivalent	Instrumentation Laboratory CO
K091980	ACL TOP 700 LAS	Sep 22, 2009	Substantially Equivalent	Instrumentation Laboratory CO
K073377	ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)	May 04, 2008	Substantially Equivalent	Instrumentation Laboratory CO
K063679	ACL TOP	Jan 12, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K033414	ACL TOP MODEL, TOP	Jan 12, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K031377	SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560	Sep 08, 2003	Substantially Equivalent	Dade Behring, Inc.
K023362	FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN	Dec 09, 2002	Substantially Equivalent	Fisher Diagnostics
K020979	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000	Jun 27, 2002	Substantially Equivalent	Dade Behring, Inc.
K001645	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500	Aug 04, 2000	Substantially Equivalent	Dade Behring, Inc.
K001891	MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C	Jul 12, 2000	Substantially Equivalent	Bio/Data Corp.
K001145	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000	May 11, 2000	Substantially Equivalent	Dade Behring, Inc.
K993299	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500	Dec 07, 1999	Substantially Equivalent	Dade Behring, Inc.
K993174	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000	Nov 09, 1999	Substantially Equivalent	Dade Behring, Inc.
K992763	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500	Sep 21, 1999	Substantially Equivalent	Dade Behring, Inc.
K992423	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500	Sep 21, 1999	Substantially Equivalent	Dade Behring, Inc.
K992321	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000	Sep 17, 1999	Substantially Equivalent	Dade Behring, Inc.
K991101	COAG-A-MATE MAX	Jun 01, 1999	Substantially Equivalent	Organon Teknika Corp.
K981206	TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)	May 26, 1998	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K964139	SYSMEX CA-6000	Feb 06, 1997	Substantially Equivalent	Dade Intl., Inc.
K962857	COAG-A-MATE MTX	Jan 22, 1997	Substantially Equivalent	Organon Teknika Corp.
K962664	ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER	Sep 10, 1996	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K961991	ACL 6000 SYSTEM (ACL 6000)	Sep 04, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K961579	STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER	Jul 10, 1996	Substantially Equivalent	American Bioproducts Co.
K954437	THROMBELASTOGRAPH COAGULATION ANALYZER 3000S	Jan 30, 1996	Substantially Equivalent	Haemoscope Corp.
K951072	PROTIME MICROCOAGULATION SYSTEM	Oct 27, 1995	Substantially Equivalent	International Technidyne Corp.
K943153	MICROSAMPLE COAGULATION ANALYZER	Mar 24, 1995	Substantially Equivalent	Bio/Data Corp.
K944227	ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER	Feb 03, 1995	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K942117	STA AUTOMATED MULTI-PARAMETRIC ANALYZER	Feb 01, 1995	Substantially Equivalent	American Bioproducts Co.
K931992	HEMOLAB	Dec 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K933092	TAS ANALYZER	Nov 15, 1993	Substantially Equivalent	Cardiovascular Diagnostic Services
K931956	CASCADE M, CAT. NO. 1710	Aug 23, 1993	Substantially Equivalent	Helena Laboratories
K931206	ELECTRA 1600C AUTOMATIC COAGULATION TIMER	Aug 23, 1993	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K924098	IL MCL-2 COAGULATION ANALYZER	Jun 18, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K921465	CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)	Jun 29, 1992	Substantially Equivalent	Helena Laboratories
K921363	CASCADE 480	Jun 09, 1992	Substantially Equivalent	Helena Laboratories
K914946	CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION	Jan 13, 1992	Substantially Equivalent	Helena Laboratories
K904297	ST-4 COAGULATION INSTRUMENT	Nov 13, 1990	Substantially Equivalent	American Bioproducts Co.
K904204	THROMBELASTOGRAPH	Nov 01, 1990	Substantially Equivalent	Haemoscope Corp.
K901380	CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430	May 25, 1990	Substantially Equivalent	Helena Laboratories
K901120	KOAGULAB 60-S COAGULATION SYSTEM	May 22, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K895844	THROMBELASTOGRAPH(R)	Oct 24, 1989	Substantially Equivalent	Haemoscope Corp.
K894052	ELECTRA 1000C AUTOMATIC COAGULATION TIMER	Jul 27, 1989	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K885035	KOAGULAB* 32-S COAGULATION SYSTEM	Feb 03, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K884863	ELECTRA 900C AUTOMATIC COAGULATION TIMER	Feb 03, 1989	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K881281	COAG-A-MATE(R) XM	May 18, 1988	Substantially Equivalent	Organon Teknika Corp.
K813564	COAG-A-MATE X2	Jan 28, 1982	Substantially Equivalent	General Diagnostics