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FDA 510(k) Application Details - K972231
Device Classification Name
System, Test, Infectious Mononucleosis
More FDA Info for this Device
510(K) Number
K972231
Device Name
System, Test, Infectious Mononucleosis
Applicant
WYNTEK DIAGNOSTICS, INC.
6146 NANCY RIDGE DR.,
SUITE 101
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
SHU-CHING CHENG
Other 510(k) Applications for this Contact
Regulation Number
866.5640
More FDA Info for this Regulation Number
Classification Product Code
KTN
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More FDA Info for this Product Code
Date Received
06/16/1997
Decision Date
08/26/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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