FDA 510(k) Application Details - K061758

Device Classification Name Radioimmunoassay, Angiotensin I And Renin

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510(K) Number K061758
Device Name Radioimmunoassay, Angiotensin I And Renin
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
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Contact SCOTT BISHOP
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Regulation Number 862.1085

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Classification Product Code CIB
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Date Received 06/22/2006
Decision Date 07/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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