# K811927: 1F Blocking Antibody (57 CO) Radioassay

- Pathway: 510(k) (Traditional)
- Applicant: Corning Medical & Scientific
- Decided: Apr 1, 1982 after 269 days
- Product code: LIG (Radioassay, Intrinsic Factor Blocking Antibody)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033603: Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999 (2003), 1 descendant of its own
- K240800: Access Intrinsic Factor Ab (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K811927
Methodology: https://510kreport.com/methodology