FDA 510(k) Application Details - K960987

Device Classification Name System, Test, Rheumatoid Factor

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510(K) Number K960987
Device Name System, Test, Rheumatoid Factor
Applicant BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM, CA 92806 US
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Contact ELIZABETH PLATT
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Regulation Number 866.5775

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Classification Product Code DHR
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Date Received 03/11/1996
Decision Date 06/04/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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