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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K901674
Device Name AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Applicant
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Tosoh Corp.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number862.2560
Classification Product Code
KHO  
Date Received04/10/1990
Decision Date 05/02/1990
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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