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FDA 510(k) Application Details - K955136
Device Classification Name
Antigens, Nontreponemal, All
More FDA Info for this Device
510(K) Number
K955136
Device Name
Antigens, Nontreponemal, All
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
866.3820
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Classification Product Code
GMQ
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More FDA Info for this Product Code
Date Received
11/13/1995
Decision Date
07/29/1996
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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