Atlas FDA

GKP

49 FDA 510(k) clearances · Product code

71 daysmedian time to decision
256 days90th percentile
49clearances measured

FDA profile

Official device name
Instrument, Coagulation, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5400
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 13 · 2017: 18 · 2018: 19 · 2019: 38 · 2020: 14 · 2021: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (K242127)Instrumentation Laboratory (IL) Co.2024-08-16
ACL TOP Family 70 Series (K231031)Instrumentation Laboratory Company2023-06-21
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) (K160276)Instrumentation Laboratory CO2016-03-03
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS (K150877)Instrumentation Laboratory CO2015-12-13
ACL TOP 700 LAS (K091980)Instrumentation Laboratory CO2009-09-22
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (K073377)Instrumentation Laboratory CO2008-05-04
ACL TOP (K063679)Instrumentation Laboratory CO2007-01-12
ACL TOP MODEL, TOP (K033414)Instrumentation Laboratory CO2004-01-12
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 (K031377)Dade Behring, Inc.2003-09-08
FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN (K023362)Fisher Diagnostics2002-12-09
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (K020979)Dade Behring, Inc.2002-06-27
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K001645)Dade Behring, Inc.2000-08-04
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (K001891)Bio/Data Corp.2000-07-12
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K001145)Dade Behring, Inc.2000-05-11
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K993299)Dade Behring, Inc.1999-12-07
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K993174)Dade Behring, Inc.1999-11-09
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992423)Dade Behring, Inc.1999-09-21
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 (K992763)Dade Behring, Inc.1999-09-21
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 (K992321)Dade Behring, Inc.1999-09-17
COAG-A-MATE MAX (K991101)Organon Teknika Corp.1999-06-01
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) (K981206)Cardiovascular Diagnostics, Inc.1998-05-26
SYSMEX CA-6000 (K964139)Dade Intl., Inc.1997-02-06
COAG-A-MATE MTX (K962857)Organon Teknika Corp.1997-01-22
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (K962664)Medical Laboratory Automation Systems, Inc.1996-09-10
ACL 6000 SYSTEM (ACL 6000) (K961991)Instrumentation Laboratory CO1996-09-04
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K961579)American Bioproducts Co.1996-07-10
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S (K954437)Haemoscope Corp.1996-01-30
PROTIME MICROCOAGULATION SYSTEM (K951072)International Technidyne Corp.1995-10-27
MICROSAMPLE COAGULATION ANALYZER (K943153)Bio/Data Corp.1995-03-24
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER (K944227)Medical Laboratory Automation Systems, Inc.1995-02-03
STA AUTOMATED MULTI-PARAMETRIC ANALYZER (K942117)American Bioproducts Co.1995-02-01
HEMOLAB (K931992)Biomerieux Vitek, Inc.1994-12-22
TAS ANALYZER (K933092)Cardiovascular Diagnostic Services1993-11-15
CASCADE M, CAT. NO. 1710 (K931956)Helena Laboratories1993-08-23
ELECTRA 1600C AUTOMATIC COAGULATION TIMER (K931206)Medical Laboratory Automation Systems, Inc.1993-08-23
IL MCL-2 COAGULATION ANALYZER (K924098)Instrumentation Laboratory CO1993-06-18
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) (K921465)Helena Laboratories1992-06-29
CASCADE 480 (K921363)Helena Laboratories1992-06-09
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION (K914946)Helena Laboratories1992-01-13
ST-4 COAGULATION INSTRUMENT (K904297)American Bioproducts Co.1990-11-13
THROMBELASTOGRAPH (K904204)Haemoscope Corp.1990-11-01
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 (K901380)Helena Laboratories1990-05-25
KOAGULAB 60-S COAGULATION SYSTEM (K901120)Ortho Diagnostic Systems, Inc.1990-05-22
THROMBELASTOGRAPH(R) (K895844)Haemoscope Corp.1989-10-24
ELECTRA 1000C AUTOMATIC COAGULATION TIMER (K894052)Medical Laboratory Automation Systems, Inc.1989-07-27
ELECTRA 900C AUTOMATIC COAGULATION TIMER (K884863)Medical Laboratory Automation Systems, Inc.1989-02-03
KOAGULAB* 32-S COAGULATION SYSTEM (K885035)Ortho Diagnostic Systems, Inc.1989-02-03
COAG-A-MATE(R) XM (K881281)Organon Teknika Corp.1988-05-18
COAG-A-MATE X2 (K813564)General Diagnostics1982-01-28

Track GKP automatically

Every clearance here is in the API, with alerts when new ones post.