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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Calcium
510(k) Number K771643
Device Name NOVA 2 IONIZED CALCIUM ANALYZER
Applicant
Nova Biomedical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nova Biomedical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1145
Classification Product Code
JFP  
Date Received08/29/1977
Decision Date 09/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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