FDA 510(k) Application Details - K970420

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

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510(K) Number K970420
Device Name Station, Pipetting And Diluting, For Clinical Use
Applicant PHARMACIA, INC.
5094 ST. ANDREWS DR.
WESTERVILE, OH 43082 US
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Contact KAREN E MATIS
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Regulation Number 862.2750

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Classification Product Code JQW
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Date Received 02/03/1997
Decision Date 06/30/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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