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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K955264
Device Name NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
Applicant
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Waltham,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/15/1995
Decision Date 02/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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