# K933078: Beckman Alpha-1-Microglobulin (A1M) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jan 11, 1994 after 202 days
- Product code: MGA (Alpha-1 Microglobulin, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K973928: Beckman Urine Protein Calibrator (Ucal) (1997), 1 descendant of its own
- K994325: Synchron CX Systems Microalbumin Calibrator (2000), 0 descendants of its own
- K965033: Immage Immunochemistry System Alpha-1-Microglobulin (AI) Reagent (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K933078
Methodology: https://510kreport.com/methodology