# K811832: Precinorm U & Precipath U Human Serum

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 15, 1981 after 16 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 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
- K992900: Precinorm Universal and Precipath Universal Control Sera (1999), 18 descendants of its own
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (2004), 17 descendants of its own
- K993360: Precinorm Universal Plus and Precipath Universal Plus Control Sera (1999), 4 descendants of its own
- K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera (2004), 3 descendants of its own
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own

Source page: https://510kreport.com/device/K811832
Methodology: https://510kreport.com/methodology