FDA 510(k) Application Details - K020610

Device Classification Name Heavy Metals Control Materials

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510(K) Number K020610
Device Name Heavy Metals Control Materials
Applicant BIO-RAD
9500 JERONIMO RD.
IRVINE, CA 92618 US
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Contact Yvette Lloyd
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Regulation Number 862.3280

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Classification Product Code DIE
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Date Received 02/25/2002
Decision Date 04/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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