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FDA 510(k) Application Details - K965151
Device Classification Name
Culture Media, Non-Propagating Transport
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510(K) Number
K965151
Device Name
Culture Media, Non-Propagating Transport
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA, KS 66215 US
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Contact
MARY ANN SILVIUS
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Regulation Number
866.2390
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Classification Product Code
JSM
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More FDA Info for this Product Code
Date Received
12/23/1996
Decision Date
01/22/1997
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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