IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT

Transferrin, Antigen, Antiserum, Control

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immunochemistry Sys Urine Transferrin Reagent.

Pre-market Notification Details

Device IDK963976
510k NumberK963976
Device Name:IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
ClassificationTransferrin, Antigen, Antiserum, Control
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 CodeDDG  
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-04
Decision Date1997-03-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590180157 K963976 000

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