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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 K901695
Device Name QUICK CHEM II
Applicant
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact J SULLIVAN
Correspondent
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact J SULLIVAN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received04/10/1990
Decision Date 05/24/1990
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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