Medical Device Manufacturer · US , Parsippany , NJ

American Bioproducts Co.

79 submissions · 75 cleared · Since 1985
79
Total
75
Cleared
0
Denied

American Bioproducts Co. — FDA 510(k) Submissions

American Bioproducts Co. has submitted 79 FDA 510(k) premarket notifications since 1985, of which 75 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Qualitative And Quantitative Factor Deficiency, Plasma, Coagulation Factor Deficient, Assay, Heparin, Plasma, Coagulation Control, Control, Plasma, Abnormal . Use the specialty filter in the sidebar to narrow results.

79 devices
1–25 of 79
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · JPA System, Multipurpose For... · Hematology
Nov 1998 43d
ASSERACHROM TPA TEST KIT
K971519 · GGP Test, Qualitative And... · Hematology
Aug 1997 116d
STA LIATEST CONTROL [N]+[P] KIT
K964716 · GGN Plasma, Coagulation Control · Hematology
Jun 1997 213d
STA-LIATEST D-DI TEST KIT
K964728 · DAP Fibrinogen And Fibrin... · Hematology
Jun 1997 213d
STA D-DI CALIBRATOR KIT
K964718 · DAP Fibrinogen And Fibrin... · Hematology
May 1997 179d
STA - LIATEST VWF TEST KIT
K962675 · GJT Plasma, Coagulation... · Hematology
Oct 1996 108d
STA-VWF CALIBRATOR KIT
K962671 · GJT Plasma, Coagulation... · Hematology
Sep 1996 66d
STA - VWF CONTROL [N]+[P] KIT
K962674 · GGN Plasma, Coagulation Control · Hematology
Jul 1996 14d
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · GKP Instrument, Coagulation,... · Hematology
Jul 1996 77d
AT-III CONTROL PLASMA KIT
K955040 · GGC Control, Plasma, Abnormal · Hematology
Jan 1996 89d
ASSERACHROM FREE PROTEIN S KIT
K954017 · GGP Test, Qualitative And... · Hematology
Nov 1995 80d
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · GGP Test, Qualitative And... · Hematology
Nov 1995 77d
THE HEPANORM HBPM/LMWH KIT
K943514 · KFF Assay, Heparin · Hematology
Sep 1995 432d
HBPM/LMWH CONTROL KIT
K943519 · KFF Assay, Heparin · Hematology
Sep 1995 432d
HEPARIN CONTROL KIT
K943520 · KFF Assay, Heparin · Hematology
Sep 1995 432d
STA-COAG CONTROL [P] PLUS KIT
K952338 · GGC Control, Plasma, Abnormal · Hematology
Sep 1995 125d
ROTACHROM HEPARIN TEST KIT
K943515 · KFF Assay, Heparin · Hematology
Aug 1995 406d
ROTACHROM HBPM/LMWH TEST KIT
K943516 · KFF Assay, Heparin · Hematology
Aug 1995 406d
THE STACHROM HEPARIN ASSAY KIT
K925433 · KFF Assay, Heparin · Hematology
May 1995 937d
STACLOT HEPARIN TEST KIT
K943517 · KFF Assay, Heparin · Hematology
May 1995 294d
AT-III CALIBRATOR
K944279 · JBQ Antithrombin Iii... · Hematology
Apr 1995 220d
PTT-LT TEST KIT
K941210 · GGW Test, Time, Partial... · Hematology
Mar 1995 372d
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · GGN Plasma, Coagulation Control · Hematology
Mar 1995 243d
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · GKP Instrument, Coagulation,... · Hematology
Feb 1995 274d
STAGO FACTOR V-DEFICIENT PLASMA
K934605 · GJT Plasma, Coagulation... · Hematology
Mar 1994 155d

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