SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM


Device Classification Name

centrifuges (micro, ultra, refrigerated) for clinical use

510(k) Number K103340
Device Name SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
Applicant
HARVEST TECHNOLOGIES, CORP.
40 grissom rd, suite 100
plymouth, 
MA 
02360

Applicant Contact john d bonasera
Correspondent
HARVEST TECHNOLOGIES, CORP.
40 grissom rd, suite 100
plymouth, 
MA 
02360

Correspodent Contact john d bonasera
Regulation Number 862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received 11/15/2010
Decision Date 12/06/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No