VACUETTE WITH PPACK


codes

Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K002777
Device Name VACUETTE WITH PPACK
Original Applicant
GREINER VACUETTE NORTH AMERICA, INC.
p.o. box 6581
ellicott city, 
MD 
21042 -0581

Original Contact judi smith
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 09/06/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No