VACUETTE TRACE ELEMENTS TUBES


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K023971
Device Name VACUETTE TRACE ELEMENTS TUBES
Original Applicant
GREINER BIO-ONE VACUETTE NORTH AMERICA
po box 103
baldwin, 
MD 
21013

Original Contact judi smith
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 11/29/2002
Decision Date 01/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No