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FDA 510(k) Application Details - K972359
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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510(K) Number
K972359
Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant
REMEL, L.P.
12076 SANTA FE DR.
LENEXA, KS 66215-3594 US
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Contact
MARY ANN SILVIUS
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Regulation Number
866.1700
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Classification Product Code
JSO
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More FDA Info for this Product Code
Date Received
06/25/1997
Decision Date
08/28/1997
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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