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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K962033
Device Name CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Applicant Contact DAVE D SMITH
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO,  CA  92690 -6130
Correspondent Contact DAVE D SMITH
Regulation Number862.1545
Classification Product Code
CEW  
Date Received05/24/1996
Decision Date 09/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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