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FDA 510(k) Application Details - K964315
Device Classification Name
Kit, Screening, Staphylococcus Aureus
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510(K) Number
K964315
Device Name
Kit, Screening, Staphylococcus Aureus
Applicant
REMEL, L.P.
P.O. BOX 16276
AUGUSTA, GA 30919-2276 US
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Contact
DAVID A WALL
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Regulation Number
866.2660
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Classification Product Code
JWX
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More FDA Info for this Product Code
Date Received
10/29/1996
Decision Date
02/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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