FDA 510(k) Application Details - K024067

Device Classification Name System, Test, Rheumatoid Factor

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510(K) Number K024067
Device Name System, Test, Rheumatoid Factor
Applicant ABBOTT LABORATORIES
1920 HURD DR.
IRVING, TX 75038 US
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Contact LINDA MORRIS
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Regulation Number 866.5775

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Classification Product Code DHR
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Date Received 12/10/2002
Decision Date 01/15/2003
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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