IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT

Albumin, Antigen, Antiserum, Control

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Albumin (alb) Reagent.

Pre-market Notification Details

Device IDK964695
510k NumberK964695
Device Name:IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
ClassificationAlbumin, Antigen, Antiserum, Control
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
ContactFrank Marte
CorrespondentFrank Marte
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
Product CodeDCF  
CFR Regulation Number866.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-22
Decision Date1997-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590223250 K964695 000
15099590221201 K964695 000

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