FDA 510(k) Application Details - K962601

Device Classification Name Radioimmunoassay, Acth

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510(K) Number K962601
Device Name Radioimmunoassay, Acth
Applicant NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO, CA 92690-6130 US
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Contact DAVE D SMITH
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Regulation Number 862.1025

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Classification Product Code CKG
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Date Received 07/02/1996
Decision Date 12/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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