IN VITRO DIAG. FOR URIC ACID

Acid, Uric, Uricase (u.v.)

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for In Vitro Diag. For Uric Acid.

Pre-market Notification Details

Device IDK770767
510k NumberK770767
Device Name:IN VITRO DIAG. FOR URIC ACID
ClassificationAcid, Uric, Uricase (u.v.)
Applicant SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-04-28
Decision Date1977-07-05

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