SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200


the company

Device Classification Name

test, qualitative and quantitative factor deficiency

510(k) Number K000398
Device Name SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
Original Applicant
SHIELD DIAGNOSTICS, LTD.
the technology park
dundee, 

GB

dd2 1sw

Original Contact eileen mccafferty
Regulation Number 864.7290
Classification Product Code
GGP  
Date Received 02/07/2000
Decision Date 04/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No