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FDA 510(k) Application Details - K962615
Device Classification Name
Strip, Test Isoniazid
More FDA Info for this Device
510(K) Number
K962615
Device Name
Strip, Test Isoniazid
Applicant
FERGUSON MEDICAL
3407 BAY AVE.
CHICO, CA 95973-8619 US
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Contact
FRANK FERGUSON
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MIG
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More FDA Info for this Product Code
Date Received
07/03/1996
Decision Date
03/19/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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