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FDA 510(k) Application Details - K991532
Device Classification Name
System, Test, Human Chorionic Gonadotropin
More FDA Info for this Device
510(K) Number
K991532
Device Name
System, Test, Human Chorionic Gonadotropin
Applicant
METRIKA, INC.
510 OAKMEAD PKWY.
SUNNYVALE, CA 94085-4022 US
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Contact
YA-CHEN HSU
Other 510(k) Applications for this Contact
Regulation Number
862.1155
More FDA Info for this Regulation Number
Classification Product Code
DHA
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More FDA Info for this Product Code
Date Received
05/03/1999
Decision Date
09/17/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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