FDA 510(k) Application Details - K021941

Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection

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510(K) Number K021941
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant ITL CORPORATION, PTY LTD.
41-45 TENNANT ST.
FYSHWICK, CANBERRA ACT 2609 AU
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Contact WILIAM L MOBBS
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 06/13/2002
Decision Date 07/02/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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