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510(k) K933078

Device
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
510(k) number
K933078
Product code
MGA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-11
Date received
1993-06-23
Regulation
866.5400
Classification name
Alpha-1 Microglobulin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM RYAN
Address
200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MGA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K965033IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENTBeckman Instruments, Inc.1997-04-21

Legacy Summary#

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FDA Review#

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