FDA Product Code GKP: Instrument, Coagulation, Automated
Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Helena Laboratories.
49
Total
49
Cleared
108d
Avg days
1982
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
28d
recently vs 109d historically
FDA 510(k) Cleared Instrument, Coagulation, Automated Devices (Product Code GKP)
49 devices
Cleared
Aug 16, 2024
ACL TOP Family 50 Series (ACL TOP 750
Instrumentation Laboratory (IL) Co.
Hematology
28d
Cleared
Jun 21, 2023
ACL TOP Family 70 Series
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)
Instrumentation Laboratory CO
Hematology
30d
Cleared
Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
Instrumentation Laboratory CO
Hematology
256d
Cleared
Sep 22, 2009
ACL TOP 700 LAS
Instrumentation Laboratory CO
Hematology
83d
Cleared
May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Instrumentation Laboratory CO
Hematology
153d
Cleared
Jan 12, 2007
ACL TOP
Instrumentation Laboratory CO
Hematology
32d
Cleared
Jan 12, 2004
ACL TOP MODEL, TOP
Instrumentation Laboratory CO
Hematology
77d
Cleared
Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Dade Behring, Inc.
Hematology
130d
Cleared
Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
Dade Behring, Inc.
Hematology
93d
Cleared
Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Dade Behring, Inc.
Hematology
66d
Cleared
May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
Dade Behring, Inc.
Hematology
31d
Cleared
Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Dade Behring, Inc.
Hematology
67d
Cleared
Nov 09, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
Dade Behring, Inc.
Hematology
48d
Cleared
Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
Dade Behring, Inc.
Hematology
62d
Cleared
Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
Dade Behring, Inc.
Hematology
35d
Cleared
Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
Dade Behring, Inc.
Hematology
67d
Cleared
Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
Instrumentation Laboratory CO
Hematology
106d
Cleared
Aug 23, 1993
CASCADE M, CAT. NO. 1710
Helena Laboratories
Hematology
125d
Cleared
Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
Instrumentation Laboratory CO
Hematology
309d
Cleared
Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
Helena Laboratories
Hematology
94d
Cleared
Jun 09, 1992
CASCADE 480
Helena Laboratories
Hematology
81d
Cleared
Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
Helena Laboratories
Hematology
76d
Cleared
May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
Helena Laboratories
Hematology
64d
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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - GKP Product Code
Recent submissions under GKP have taken an average of 28 days to reach a decision - down from 109 days historically, suggesting improved FDA processing for this classification.
GKP devices are reviewed by the Hematology panel. Browse all Hematology devices →