URIC ACID TEST

Acid, Uric, Uricase (colorimetric)

U. S. DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Uric Acid Test.

Pre-market Notification Details

Device IDK864119
510k NumberK864119
Device Name:URIC ACID TEST
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-21
Decision Date1986-10-29

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