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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K843668
Device Name PHOTOMETER 90IYS
Applicant
Institute Virion , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Institute Virion , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/17/1984
Decision Date 10/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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