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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K950142
Device Name CR PERFECT
Applicant
Chimera Research & Chemical, Inc.
10360 72nd St. N.
Largo,  FL 
Applicant Contact JACK V SMITH
Correspondent
Chimera Research & Chemical, Inc.
10360 72nd St. N.
Largo,  FL 
Correspondent Contact JACK V SMITH
Regulation Number862.1225
Classification Product Code
CGX  
Date Received01/13/1995
Decision Date 05/25/1995
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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