GKP · Class II · 21 CFR 864.5400

FDA Product Code GKP: Instrument, Coagulation, Automated

Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Medical Laboratory Automation Systems, Inc..

49
Total
49
Cleared
108d
Avg days
1982
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Instrument, Coagulation, Automated Devices (Product Code GKP)

49 devices
1–24 of 49
Cleared Aug 16, 2024
ACL TOP Family 50 Series (ACL TOP 750
K242127
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Jun 21, 2023
ACL TOP Family 70 Series
K231031
Instrumentation Laboratory Company
Hematology · 71d
Cleared Mar 03, 2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
K160276
Instrumentation Laboratory CO
Hematology · 30d
Cleared Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877
Instrumentation Laboratory CO
Hematology · 256d
Cleared Sep 22, 2009
ACL TOP 700 LAS
K091980
Instrumentation Laboratory CO
Hematology · 83d
Cleared May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377
Instrumentation Laboratory CO
Hematology · 153d
Cleared Jan 12, 2007
ACL TOP
K063679
Instrumentation Laboratory CO
Hematology · 32d
Cleared Jan 12, 2004
ACL TOP MODEL, TOP
K033414
Instrumentation Laboratory CO
Hematology · 77d
Cleared Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
K031377
Dade Behring, Inc.
Hematology · 130d
Cleared Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362
Fisher Diagnostics
Hematology · 63d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979
Dade Behring, Inc.
Hematology · 93d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645
Dade Behring, Inc.
Hematology · 66d
Cleared Jul 12, 2000
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
K001891
Bio/Data Corp.
Hematology · 21d
Cleared May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145
Dade Behring, Inc.
Hematology · 31d
Cleared Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299
Dade Behring, Inc.
Hematology · 67d
Cleared Nov 09, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174
Dade Behring, Inc.
Hematology · 48d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992423
Dade Behring, Inc.
Hematology · 62d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763
Dade Behring, Inc.
Hematology · 35d
Cleared Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321
Dade Behring, Inc.
Hematology · 67d
Cleared Jun 01, 1999
COAG-A-MATE MAX
K991101
Organon Teknika Corp.
Hematology · 61d
Cleared May 26, 1998
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
K981206
Cardiovascular Diagnostics, Inc.
Hematology · 55d
Cleared Feb 06, 1997
SYSMEX CA-6000
K964139
Dade Intl., Inc.
Hematology · 114d
Cleared Jan 22, 1997
COAG-A-MATE MTX
K962857
Organon Teknika Corp.
Hematology · 184d
Cleared Sep 10, 1996
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K962664
Medical Laboratory Automation Systems, Inc.
Hematology · 63d

About Product Code GKP - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code GKP since 1982, with 49 receiving FDA clearance (average review time: 108 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.