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FDA 510(k) Application Details - K960090
Device Classification Name
Stains, Microbiologic
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510(K) Number
K960090
Device Name
Stains, Microbiologic
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA, KS 66215 US
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Contact
MARY ANN SILVIUS
Other 510(k) Applications for this Contact
Regulation Number
864.1850
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Classification Product Code
JTS
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More FDA Info for this Product Code
Date Received
01/11/1996
Decision Date
03/19/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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