FDA 510(k) Application Details - K960491

Device Classification Name Radioimmunoassay, Acth

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510(K) Number K960491
Device Name Radioimmunoassay, Acth
Applicant HAWKSLEY & SONS LTD.
MARLBOROUGH RD.
LANCING BUSINESS PARK
LANCING, WEST SUSSEX BN15 8TN GB
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Contact J.A. J DINNING
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Regulation Number 862.1025

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Classification Product Code CKG
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Date Received 02/01/1996
Decision Date 10/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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