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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 K781884
Device Name SERUM, CREATININE DETERMINATIONS
Applicant
FISHER SCIENTIFIC CO., LLC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FISHER SCIENTIFIC CO., LLC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1225
Classification Product Code
CGX  
Date Received11/07/1978
Decision Date 12/20/1978
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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