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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K935408
Device Name UA PERFECT
Applicant
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Applicant Contact JACK V SMITH
Correspondent
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Correspondent Contact JACK V SMITH
Regulation Number862.2900
Classification Product Code
KQO  
Date Received11/09/1993
Decision Date 06/13/1994
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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