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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K841464
Device Name CHANGES IN THE CHEMICAL COMP. OF 5
Applicant
NOVA BIOMEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NOVA BIOMEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/12/1984
Decision Date 06/22/1984
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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