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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 K003247
Device Name CREATININE
Applicant
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1225
Classification Product Code
CGX  
Date Received10/17/2000
Decision Date 12/14/2000
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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