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FDA 510(k) Application Details - K971653
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K971653
Device Name
Glucose Oxidase, Glucose
Applicant
CLINICAL DIAGNOSTICS, INC.
609 COLUMBIA RD.
CHESTER, SC 29706 US
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Contact
RHONDA P BLANTON
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Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
05/06/1997
Decision Date
01/02/1998
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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