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FDA 510(k) Application Details - K973126
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
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510(K) Number
K973126
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
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Contact
JOHN F BRUNI
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Regulation Number
862.1215
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Classification Product Code
JHX
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More FDA Info for this Product Code
Date Received
08/20/1997
Decision Date
10/06/1997
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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