SAMPLOK LUER KIT


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K021941
Device Name SAMPLOK LUER KIT
Original Applicant
ITL CORPORATION, PTY LTD.
41-45 tennant st.
fyshwick, canberra act, 

AU

2609

Original Contact wiliam l mobbs
Regulation Number 862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received 06/13/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No