FDA 510(k) Application Details - K925998

Device Classification Name Radioimmunoassay, Angiotensin I And Renin

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510(K) Number K925998
Device Name Radioimmunoassay, Angiotensin I And Renin
Applicant NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO, CA US
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Contact SALVADORE PALOMARES
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Regulation Number 862.1085

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Classification Product Code CIB
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Date Received 11/27/1992
Decision Date 01/06/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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