QUANTITATE URIC ACID VERIFIER SET

Single (specified) Analyte Controls (assayed And Unassayed)

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Quantitate Uric Acid Verifier Set.

Pre-market Notification Details

Device IDK944453
510k NumberK944453
Device Name:QUANTITATE URIC ACID VERIFIER SET
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
ContactDon W Hart
CorrespondentDon W Hart
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1994-11-22

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