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GIL — Plasma, Fibrinogen Control Class II

FDA Device Classification

Classification Details

Product Code
GIL
Device Class
Class II
Regulation Number
864.7340
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962407behring diagnosticsN/T PROTEIN CONTROL PYJuly 29, 1996
K946265clinical controlsFIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3August 24, 1995
K946193more diagnosticsFIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3August 24, 1995
K935598clinical controlsPLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2May 2, 1995
K951012behring diagnosticsN/T PROTEIN CONTROL PYApril 17, 1995
K934741clinical controlsLIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2September 8, 1994
K915462sigma diagnosticsFIBRINOGEN CONTROLMarch 4, 1992
K833352warner-lambertGEN. DIAGNOSTICS LOW FIBRINOGEN CONTROLNovember 3, 1983