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GFO — Activated Partial Thromboplastin Class II

FDA Device Classification

Classification Details

Product Code
GFO
Device Class
Class II
Regulation Number
864.7925
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K961892analytical control systemsSPECKTIN-LA TEST SETMarch 7, 1997
K955638ortho diagnostic systemsSYNTHAFAX APTT REAGENTApril 23, 1996
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K953981ortho diagnostic systemsSYNTHASIL APTT REAGENTNovember 30, 1995
K935169helena laboratoriesAPTT-ESDecember 2, 1994
K934351medical diagnostic technologiesAPTT-ES REAGENTDecember 6, 1993
K932011behring diagnosticsPATHROMTINOctober 25, 1993