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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, uric, uricase (u.v.)
510(k) Number K770767
Device Name IN VITRO DIAG. FOR URIC ACID
Applicant
SMITH KLINE DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SMITH KLINE DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1775
Classification Product Code
CDO  
Date Received04/28/1977
Decision Date 07/05/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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