Medical Device Manufacturer · US , Mchenry , IL

Pacific Hemostasis

29 submissions · 29 cleared · Since 1978
29
Total
29
Cleared
0
Denied

Pacific Hemostasis — FDA 510(k) Submissions

Pacific Hemostasis has submitted 29 FDA 510(k) premarket notifications since 1978, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plasma, Coagulation Control, Test, Time, Prothrombin, Test, Sickle Cell, Plasma, Coagulation Factor Deficient, Control, Plasma, Abnormal . Use the specialty filter in the sidebar to narrow results.

29 devices
1–25 of 29
THROMBOSTRATE CONTROL PLASMAS
K000679 · GGN Plasma, Coagulation Control · Hematology
Mar 2000 24d
PACIFIC HEMOSTASIS THROMBOPLASTIN D
K994100 · GJS Test, Time, Prothrombin · Hematology
Feb 2000 77d
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · KQG Instrument, Coagulation · Hematology
Sep 1999 72d
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · GGN Plasma, Coagulation Control · Hematology
Aug 1999 50d
HEPARIN CONTROL PLASMA LEVEL 2
K992279 · GGN Plasma, Coagulation Control · Hematology
Aug 1999 50d
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · KQG Instrument, Coagulation · Hematology
Jun 1999 63d
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · GJT Plasma, Coagulation... · Hematology
Feb 1999 41d
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129 · GIZ Plasma, Control, Normal · Hematology
Dec 1998 13d
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · GGC Control, Plasma, Abnormal · Hematology
Dec 1998 13d
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · GGC Control, Plasma, Abnormal · Hematology
Dec 1998 13d
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
K972627 · GJT Plasma, Coagulation... · Hematology
Aug 1997 30d
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · GGN Plasma, Coagulation Control · Hematology
Jun 1997 61d
THROMBOSCREEN THROMBOPLASTIN-DS
K940082 · GJS Test, Time, Prothrombin · Hematology
Feb 1995 403d
THROMBOSCREEN APTT REAGENT
K891337 · GFO Activated Partial... · Hematology
Apr 1989 42d
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
K872217 · GHM Test, Sickle Cell · Hematology
Jul 1987 52d
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643 · LCP Assay, Glycosylated... · Hematology
Apr 1987 153d
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079 · GHM Test, Sickle Cell · Hematology
Oct 1985 24d
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · GHH Fibrin Split Products · Hematology
Sep 1985 97d
CONTACT-K APTT REAGENT
K834086 · GGN Plasma, Coagulation Control · Microbiology
Feb 1984 67d
THROMBOSCREEN
K820450 · GIT Reagent & Control,... · Hematology
Mar 1982 36d
CEA CONTROL PLASMA
K812658 · DHX System, Test,... · Immunology
Sep 1981 11d
ANTITHROMBIN III SCREEN KIT
K812215 · JBQ Antithrombin Iii... · Hematology
Sep 1981 27d
THROMBOPLASTIN
K810350 · GJS Test, Time, Prothrombin · Immunology
Apr 1981 63d
PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
K801460 · GGW Test, Time, Partial... · Hematology
Jul 1980 34d
FIBRINOGEN SCREEN
K800826 · KQJ System, Fibrinogen... · Hematology
May 1980 46d
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