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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K831830
Device Name LYRIS MODULAR INFO SYSTEM
Applicant
BIOVATION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOVATION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.2100
Classification Product Code
JQP  
Date Received06/07/1983
Decision Date 06/25/1984
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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