# K820647: Gamma Fetal Bleed Screening Test

- Pathway: 510(k) (Traditional)
- Applicant: Gamma Biologicals, Inc.
- Decided: May 12, 1982 after 64 days
- Product code: LIM (Test, Screening, For D Positive Fetal Rbc'S)
- Device class: 2
- Regulation: 21 CFR 864.7455
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

Source page: https://510kreport.com/device/K820647
Methodology: https://510kreport.com/methodology