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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 K853284
Device Name MYREADER 7
Applicant
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Applicant Contact NICOLAS SCHMELZER
Correspondent
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Correspondent Contact NICOLAS SCHMELZER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/05/1985
Decision Date 10/04/1985
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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