PLATELETWORKS, MODELS PW-A, PW-C


Device Classification Name

system, automated platelet aggregation

510(k) Number K023761
Device Name PLATELETWORKS, MODELS PW-A, PW-C
Original Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Original Contact patricia franks
Regulation Number 864.5700
Classification Product Code
JOZ  
Date Received 11/08/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No