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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., N.W.
Walker,  MI  49534
Correspondent
INSTITUTE VIRION LTD.
4221 Richmond Rd., N.W.
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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