BECKMAN URINE PROTEIN CALIBRATOR (UCAL)

Calibrator, Multi-analyte Mixture

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Urine Protein Calibrator (ucal).

Pre-market Notification Details

Device IDK973928
510k NumberK973928
Device Name:BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
ClassificationCalibrator, Multi-analyte Mixture
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
ContactAnnette Hellie
CorrespondentAnnette Hellie
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-15
Decision Date1997-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590222673 K973928 000

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