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FDA 510(k) Application Details - K001455
Device Classification Name
Radioimmunoassay, Thyroid-Stimulating Hormone
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510(K) Number
K001455
Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant
NEOMETRICS, INC.
104 BELLEROSE AVE.
EAST NORTHPORT, NY 11731 US
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Contact
DAVID SCHWARTZ
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Regulation Number
862.1690
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Classification Product Code
JLW
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More FDA Info for this Product Code
Date Received
05/09/2000
Decision Date
11/02/2000
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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