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FDA 510(k) Application Details - K970483
Device Classification Name
Radioimmunoassay, Parathyroid Hormone
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510(K) Number
K970483
Device Name
Radioimmunoassay, Parathyroid Hormone
Applicant
SEALITE SCIENCES, INC.
3000 NORTHWOODS PKWY., #200
NORCROSS, GA 30071 US
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Contact
CATHRYN N CAMBRIA
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Regulation Number
862.1545
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Classification Product Code
CEW
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More FDA Info for this Product Code
Date Received
02/10/1997
Decision Date
04/14/1997
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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