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FDA 510(k) Application Details - K972156
Device Classification Name
Antigens, All Types, Escherichia Coli
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510(K) Number
K972156
Device Name
Antigens, All Types, Escherichia Coli
Applicant
GUARDIAN SCIENTIFIC, CORP.
8990-E ROUTE 108
COLUMBIA, MD 21045 US
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Contact
KATHRYN B POWERS
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Regulation Number
866.3255
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Classification Product Code
GMZ
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Date Received
06/09/1997
Decision Date
10/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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