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FDA 510(k) Application Details - K973310
Device Classification Name
Radioimmunoassay, Luteinizing Hormone
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510(K) Number
K973310
Device Name
Radioimmunoassay, Luteinizing Hormone
Applicant
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY, NJ 08512 US
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THERESA SINES
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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
09/03/1997
Decision Date
10/27/1997
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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