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FDA 510(k) Application Details - K961423
Device Classification Name
Antisera, All Groups, Streptococcus Spp.
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510(K) Number
K961423
Device Name
Antisera, All Groups, Streptococcus Spp.
Applicant
WYNTEK DIAGNOSTICS, INC.
6145 NANCY RIDGE DR.
SUITE 101
SAN DIEGO, CA 92121 US
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Contact
SHU-CHING CHENG
Other 510(k) Applications for this Contact
Regulation Number
866.3740
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Classification Product Code
GTZ
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More FDA Info for this Product Code
Date Received
04/12/1996
Decision Date
10/11/1996
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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