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FDA 510(k) Application Details - K980012
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
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510(K) Number
K980012
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
AC BIOCHEMICALS, INC.
17955 SKY PARK CIRCLE, SUITE J
IRVINE, CA 92614 US
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Contact
CHARLES C ALLAIN
Other 510(k) Applications for this Contact
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
01/02/1998
Decision Date
02/25/1998
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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