510(k) Report

510(k) · Cleared

Cleared

1F Blocking Antibody (57 CO) Radioassay

K811927510(k) TraditionalCleared Apr 1, 1982269-day reviewClass II21 CFR 862.1810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corning Medical & Scientific · LIG Radioassay, Intrinsic Factor Blocking Antibody

Cleared on Apr 1, 1982 after a 269-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 1, 1982
Review
269 days
Class
Class II
Product code
LIG
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK811927 1F Blocking Antibody (57 CO) RadioassayCorning Medical & Scientific · 1982
  2. Descendant · cites it directly · 1 of its ownK033603 Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay…Beckman Coulter, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK240800 Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all
  • K033603Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…Beckman Coulter, Inc. · 2003 · cites it directly1descendant
  • K240800Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K8119271F Blocking Antibody (57 CO) RadioassayCorning Medical & Scientific1982—
+1K033603Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems…Beckman Coulter, Inc.2003—
+2K240800Access Intrinsic Factor AbBeckman Coulter, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
202410
FIG. 1 — Lineage of K811927, 1982–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LIG device

  1. #1 K240800 Access Intrinsic Factor Abscore 7.6 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033603Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…Beckman Coulter, Inc.20031

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033603 (Beckman Coulter, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LIG devices

LIG Radioassay, Intrinsic Factor Blocking Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIG

1in 2024

2007: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIG

Too few LIG 510(k)s in any year since 2007 to give a median.

Recalls per year · LIG

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIG

1in 2019

2018: 12019: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code LIG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—10
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

More from Corning Medical & Scientific

111 FDA decisions under this applicant name. See the company

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  • K872076Corning Disposable Roller BottlesCorning Medical & Scientific · 1987
  • K863789Corning Elisa PlatesCorning Medical & Scientific · 1986
  • K854024Corning Magic Mab HCG RadioimmunoassayCorning Medical & Scientific · 1985

Recent decisions in LIG

The LIG category page

  • K240800Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024
  • K071346Immulisa Intrinsic Factor Antibody ElisaImmco Diagnostics, Inc. · 2007
  • K061841Quanta Lite Intrinsic Factor ElisaInova Diagnostics, Inc. · 2006
  • K033603Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999Beckman Coulter, Inc. · 2003
  • K993251Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6Diagnostic Products Corp. · 19991 recall

https://510kreport.com/device/K811927 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811927: 1F Blocking Antibody (57 CO) Radioassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811927

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026