FDA 510(k) Application Details - K983442

Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone

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510(K) Number K983442
Device Name Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant ABBOTT LABORATORIES
100/200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3500 US
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Contact APRIL VEOUKAS
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Regulation Number 862.1690

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Classification Product Code JLW
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Date Received 09/30/1998
Decision Date 11/20/1998
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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