FDA 510(k) Application Details - K981312

Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone

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510(K) Number K981312
Device Name Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact GABRIEL J MURACA, JR.
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Regulation Number 862.1690

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Classification Product Code JLW
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Date Received 04/10/1998
Decision Date 06/05/1998
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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