REFACTO LABORATORY STANDARD


definition

Device Classification Name

test, qualitative and quantitative factor deficiency

510(k) Number K002350
Device Name REFACTO LABORATORY STANDARD
Original Applicant
THE GENETICS INSTITUTE
87 cambridge park dr.
cambridge, 
MA 
02140 -2387

Original Contact maryann krane
Regulation Number 864.7290
Classification Product Code
GGP  
Date Received 08/02/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No