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FDA 510(k) Application Details - K960233
Device Classification Name
Radioimmunoassay, Luteinizing Hormone
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510(K) Number
K960233
Device Name
Radioimmunoassay, Luteinizing Hormone
Applicant
VANGUARD BIOMEDICAL CORP.
10225 BARNES CANYON RD.,
SUITE A-108
SAN DIEGO, CA 92121 US
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Contact
JOHN CHJIU
Other 510(k) Applications for this Contact
Regulation Number
862.1485
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Classification Product Code
CEP
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More FDA Info for this Product Code
Date Received
01/17/1996
Decision Date
04/23/1996
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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