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FDA 510(k) Application Details - K955107
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K955107
Device Name
Glucose Oxidase, Glucose
Applicant
FIREHOUSE MEDICAL, INC.
310 WEST ORANGETHORPE AVE.
PLACENTIA, CA 92670 US
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Contact
DAVID HOLCOMBE
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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
11/08/1995
Decision Date
08/16/1996
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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