FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K961579 |
AMERICAN BIOPRODUCTS CO. |
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER |
07/10/1996 |
K001891 |
BIO/DATA CORP. |
MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C |
07/12/2000 |
K981206 |
CARDIOVASCULAR DIAGNOSTICS, INC. |
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) |
05/26/1998 |
K031377 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 |
09/08/2003 |
K020979 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 |
06/27/2002 |
K993299 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
12/07/1999 |
K001645 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
08/04/2000 |
K992423 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
09/21/1999 |
K992763 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
09/21/1999 |
K992321 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
09/17/1999 |
K993174 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
11/09/1999 |
K001145 |
DADE BEHRING, INC. |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
05/11/2000 |
K964139 |
DADE INTL., INC. |
SYSMEX CA-6000 |
02/06/1997 |
K023362 |
FISHER DIAGNOSTICS |
FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN |
12/09/2002 |
K954437 |
HAEMOSCOPE CORP. |
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S |
01/30/1996 |
K961991 |
INSTRUMENTATION LABORATORY CO. |
ACL 6000 SYSTEM (ACL 6000) |
09/04/1996 |
K063679 |
INSTRUMENTATION LABORATORY CO. |
ACL TOP |
01/12/2007 |
K160276 |
INSTRUMENTATION LABORATORY CO. |
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) |
03/03/2016 |
K073377 |
INSTRUMENTATION LABORATORY CO. |
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) |
05/04/2008 |
K091980 |
INSTRUMENTATION LABORATORY CO. |
ACL TOP 700 LAS |
09/22/2009 |
K150877 |
Instrumentation Laboratory Co. |
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
12/13/2015 |
K033414 |
INSTRUMENTATION LABORATORY CO. |
ACL TOP MODEL, TOP |
01/12/2004 |
K231031 |
Instrumentation Laboratory Company |
ACL TOP Family 70 Series |
06/21/2023 |
K962664 |
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. |
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER |
09/10/1996 |
K991101 |
ORGANON TEKNIKA CORP. |
COAG-A-MATE MAX |
06/01/1999 |
K962857 |
ORGANON TEKNIKA CORP. |
COAG-A-MATE MTX |
01/22/1997 |