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FDA 510(k) Application Details - K960561
Device Classification Name
Radioimmunoassay, Prolactin (Lactogen)
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510(K) Number
K960561
Device Name
Radioimmunoassay, Prolactin (Lactogen)
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
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Contact
JOHN WILLIS
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Regulation Number
862.1625
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Classification Product Code
CFT
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More FDA Info for this Product Code
Date Received
02/09/1996
Decision Date
04/26/1996
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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