FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN


Device Classification Name

instrument, coagulation, automated

510(k) Number K023362
Device Name FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
Original Applicant
FISHER DIAGNOSTICS
8365 valley pike
middletown, 
VA 
22645 -0307

Original Contact jerald steiner
Regulation Number 864.5400
Classification Product Code
GKP  
Subsequent Product Code
GIS  
Date Received 10/07/2002
Decision Date 12/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No