BECKMAN ALPHA-1-MICROGLOBULIN (A1M) 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 Beckman Alpha-1-microglobulin (a1m) Reagent.

Pre-market Notification Details

Device IDK933078
510k NumberK933078
Device Name:BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
ClassificationAlpha-1 Microglobulin, Antigen, Antiserum, Control
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactWilliam Ryan
CorrespondentWilliam Ryan
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 Received1993-06-23
Decision Date1994-01-11

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