GKP

Product Code: GKP


Products Classified as GKP

2314Instrument, Coagulation, AutomatedCoagulation Instrument.

Total Product Life Cycle (TPLC) Devices

2314Instrument, Coagulation, AutomatedCoagulation Instrument.

FDA Consensus Standards

Instrument, Coagulation, Automated [32362]21 CFR §864.5400 🔎

Pre-market Notifications for GKP

K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)INSTRUMENTATION LABORATORY CO.
K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LASInstrumentation Laboratory Co.
K091980ACL TOP 700 LASINSTRUMENTATION LABORATORY CO.
K073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)INSTRUMENTATION LABORATORY CO.
K063679ACL TOPINSTRUMENTATION LABORATORY CO.
K033414ACL TOP MODEL, TOPINSTRUMENTATION LABORATORY CO.
K031377SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560DADE BEHRING, INC.
K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINFISHER DIAGNOSTICS
K020979SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000DADE BEHRING, INC.
K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CBIO/DATA CORP.
K001645SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500DADE BEHRING, INC.
K001145SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000DADE BEHRING, INC.
K993299SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500DADE BEHRING, INC.
K993174SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000DADE BEHRING, INC.
K992763SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500DADE BEHRING, INC.

Global Unique Device Identification Database

00630414945514INSTRUMENT, COAGULATION, AUTOMATED
00842768014444INSTRUMENT, COAGULATION, AUTOMATED
00842768012198INSTRUMENT, COAGULATION, AUTOMATED
00842768008023INSTRUMENT, COAGULATION, AUTOMATED
04987562425716INSTRUMENT, COAGULATION, AUTOMATED
04987562205936INSTRUMENT, COAGULATION, AUTOMATED
08426950452867Instrument, Coagulation, Automated
08426950003328INSTRUMENT, COAGULATION, AUTOMATED
08426950928027INSTRUMENT, COAGULATION, AUTOMATED
08426950928010INSTRUMENT, COAGULATION, AUTOMATED
08426950928003INSTRUMENT, COAGULATION, AUTOMATED
08426950784067INSTRUMENT, COAGULATION, AUTOMATED
08426950784050INSTRUMENT, COAGULATION, AUTOMATED
08426950729242INSTRUMENT, COAGULATION, AUTOMATED
08426950556916INSTRUMENT, COAGULATION, AUTOMATED

Maude Adverse Events

BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2020-01-27
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-11-27
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-11-05
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-10-24
ACL TOP 500 CTSINSTRUMENTATION LABORATORY2019-09-03
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-08-16
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-08-16
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-07-23
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-06-24
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-06-18
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-25
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-19
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-03-08
ACL TOP 550 CTSINSTRUMENTATION LABORATORY2019-03-01
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-01-10
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-01-10
ACL TOP 500 CTSINSTRUMENTATION LABORATORY2019-01-08
ACL TOP 500 CTSINSTRUMENTATION LABORATORY2018-10-31
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-10-02
SYSMEX CA-660SYSMEX RA CO., LTD. MAIN PLANT2018-08-30
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-21
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-21
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-14
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-20
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-12
BCS XPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-06-22
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-06-15
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-05-25
BCS XPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-05-22
BCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-04-06
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.