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FDA 510(k) Application Details - K964635
Device Classification Name
Radioimmunoassay, Calcitonin
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510(K) Number
K964635
Device Name
Radioimmunoassay, Calcitonin
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
862.1140
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Classification Product Code
JKR
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More FDA Info for this Product Code
Date Received
11/19/1996
Decision Date
05/21/1997
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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