FDA 510(k) Application Details - K962015

Device Classification Name System, Test, Rheumatoid Factor

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510(K) Number K962015
Device Name System, Test, Rheumatoid Factor
Applicant TECO DIAGNOSTICS
911 VIA RODEO
PLACENTIA, CA 92670 US
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Contact K.C. CHEN, PH.D.
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Regulation Number 866.5775

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Classification Product Code DHR
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Date Received 05/22/1996
Decision Date 11/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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