DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP


the company

Device Classification Name

system, automated platelet aggregation

510(k) Number K002885
Device Name DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
Original Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Original Contact radames riesgo
Regulation Number 864.5700
Classification Product Code
JOZ  
Date Received 09/15/2000
Decision Date 06/21/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized