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510(k) K811927

Device
1F BLOCKING ANTIBODY(57 CO) RADIOASSAY
Applicant
CORNING MEDICAL & SCIENTIFIC
510(k) number
K811927
Product code
LIG  
Decision
Substantially Equivalent (SESE)
Decision date
1982-04-01
Date received
1981-07-06
Regulation
862.1810
Classification name
Radioassay, Intrinsic Factor Blocking Antibody
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240800Access Intrinsic Factor AbBeckman Coulter, Inc.2024-05-03
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

Legacy Summary#

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FDA Review#

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