SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT

Acid, Uric, Uricase (colorimetric)

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx Systems Uric Acid (uric) Reagent.

Pre-market Notification Details

Device IDK970919
510k NumberK970919
Device Name:SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactSheri Hall
CorrespondentSheri Hall
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-12
Decision Date1997-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590575281 K970919 000

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