IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT

Alpha-1 Microglobulin, 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 Alpha-1-microglobulin (ai) Reagent.

Pre-market Notification Details

Device IDK965033
510k NumberK965033
Device Name:IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
ClassificationAlpha-1 Microglobulin, Antigen, Antiserum, Control
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactAnnette Hellie
CorrespondentAnnette Hellie
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeMGA  
CFR Regulation Number866.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-17
Decision Date1997-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590180140 K965033 000

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