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FDA 510(k) Application Details - K990258
Device Classification Name
Test,Immunoassay,Biosensor,Hcg
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510(K) Number
K990258
Device Name
Test,Immunoassay,Biosensor,Hcg
Applicant
QUANTECH LTD.
9418 LASAINE AVE.
NORTHRIDGE, CA 91325 US
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Contact
ROBIN HELLEN
Other 510(k) Applications for this Contact
Regulation Number
862.1155
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Classification Product Code
NAL
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More FDA Info for this Product Code
Date Received
01/27/1999
Decision Date
12/21/1999
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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