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FDA 510(k) Application Details - K971466
Device Classification Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
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510(K) Number
K971466
Device Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Applicant
CAROLINA LIQUID CHEMISTRIES CORP.
451 WEST LAMBERT RD.,
SUITE 207
BREA, CA 92821 US
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Contact
CYNTHIA SHUGART
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Regulation Number
862.1360
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Classification Product Code
JQB
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More FDA Info for this Product Code
Date Received
04/22/1997
Decision Date
05/06/1997
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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