SECQUIRE CELL SEPARATOR


Device Classification Name

centrifuges (micro, ultra, refrigerated) for clinical use

510(k) Number K024080
Device Name SECQUIRE CELL SEPARATOR
Original Applicant
PERFUSION PARTNERS & ASSOC. INC.
p.o. box 4341
crofton, 
MD 
21114

Original Contact e.j. smith
Regulation Number 862.2050
Classification Product Code
JQC  
Date Received 12/10/2002
Decision Date 07/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No