FDA 510(k) Application Details - K980180

Device Classification Name Station, Pipetting And Diluting, For Clinical Use

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510(K) Number K980180
Device Name Station, Pipetting And Diluting, For Clinical Use
Applicant WATERS CORPORATION
34 MAPLE ST.
MILFORD, MA 01757-3696 US
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Contact VIRGINIA L CORBIN
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Regulation Number 862.2750

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Classification Product Code JQW
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Date Received 01/20/1998
Decision Date 02/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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