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FDA 510(k) Application Details - K971967
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
More FDA Info for this Device
510(K) Number
K971967
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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
862.1770
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Classification Product Code
CDQ
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More FDA Info for this Product Code
Date Received
05/28/1997
Decision Date
06/17/1997
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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