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FDA 510(k) Application Details - K002638
Device Classification Name
Radioimmunoassay, Acth
More FDA Info for this Device
510(K) Number
K002638
Device Name
Radioimmunoassay, Acth
Applicant
FUTURE DIAGNOSTICS B.V.
4079 MT. BARNARD
SAN DIEGO, CA 92111 US
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Contact
DAVE D SMITH
Other 510(k) Applications for this Contact
Regulation Number
862.1025
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Classification Product Code
CKG
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More FDA Info for this Product Code
Date Received
08/24/2000
Decision Date
01/17/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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