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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 K901965
Device Name MPR-4A - MICRO-PLATE READER
Applicant
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/30/1990
Decision Date 05/10/1990
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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