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FDA 510(k) Application Details - K971309
Device Classification Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
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510(K) Number
K971309
Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant
DERMA MEDIA LAB., INC.
8531 WELLSFORD PL., SUITE E
SANTA FE SPRINGS, CA 90670 US
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Contact
CHARLES C ALLAIN
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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
04/08/1997
Decision Date
08/01/1997
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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