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510(k) K240800

Device
Access Intrinsic Factor Ab
Applicant
Beckman Coulter, Inc.
510(k) number
K240800
Product code
LIG
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-03
Date received
2024-03-25
Regulation
862.1810
Classification name
Radioassay, Intrinsic Factor Blocking Antibody
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Oelberg
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071346IMMULISA INTRINSIC FACTOR ANTIBODY ELISAImmco Diagnostics, Inc.2007-09-24
K061841QUANTA LITE INTRINSIC FACTOR ELISAInova Diagnostics, Inc.2006-12-22
K033603INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999Beckman Coulter, Inc.2003-12-19
K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6Diagnostic Products Corp.1999-11-17
K984108ABBOTT ARCHITECT B12Abbott Laboratories1999-02-03
K903218IMX B12Abbott Laboratories1990-08-23
K8119271F BLOCKING ANTIBODY(57 CO) RADIOASSAYCorning Medical & Scientific1982-04-01