# K972812: Raichem Prealbumin Spia

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Aug 28, 1997 after 31 days
- Product code: DDS (Prealbumin, Fitc, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884297 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884297: SPQ (TM) Test System for Prealbumin, Atlantic Antibodies (1988) Summary page 1.

## Indications for use
The use of these reagents is indicated for the measurement of prealbumin levels in human serum or plasma.

Source page: https://510kreport.com/device/K972812
Methodology: https://510kreport.com/methodology