FDA 510(k) Application Details - K010668

Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella

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510(K) Number K010668
Device Name Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant BAYER CORP.
63 NORTH ST.
MEDFIELD, MA 02052-1688 US
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Contact William J Pignato
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Regulation Number 866.3510

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Classification Product Code LFX
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Date Received 03/06/2001
Decision Date 07/05/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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