Pacific Hemostasis

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
29
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000679THROMBOSTRATE CONTROL PLASMASMarch 24, 2000
K994100PACIFIC HEMOSTASIS THROMBOPLASTIN DFebruary 18, 2000
K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CSeptember 3, 1999
K992279HEPARIN CONTROL PLASMA LEVEL 2August 26, 1999
K992278HEPARIN CONTROL PLASMA LEVEL 1August 26, 1999
K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200June 21, 1999
K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMAFebruary 17, 1999
K984131COAGULATION CONTROL LEVEL 3 (ABNORMAL)December 1, 1998
K984130COAGULATION CONTROL LEVEL 2 (ABNORMAL)December 1, 1998
K984129COAGULATION CONTROL LEVEL 1 (NORMAL)December 1, 1998
K972627PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)August 13, 1997
K971428COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0June 17, 1997
K940082THROMBOSCREEN THROMBOPLASTIN-DSFebruary 14, 1995
K891337THROMBOSCREEN APTT REAGENTApril 21, 1989
K872217THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KITJuly 31, 1987
K864643GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KITApril 28, 1987
K854079THROMBO SCREEN SICKLE CELL ASSAY SETOctober 31, 1985
K852512THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KITSeptember 17, 1985
K834086CONTACT-K APTT REAGENTFebruary 3, 1984
K820450THROMBOSCREENMarch 26, 1982