# K871027: Precinorm (R) Protein

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 15, 1987 after 60 days
- Product code: DAF (Gamma Globulin, Fitc, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K981401: Boehringer Mannheim Precinorm Precipath Protein Controls (1998), 7 descendants of its own
- K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls (2004), 5 descendants of its own
- K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc) (2004), 2 descendants of its own
- K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc (2005), 1 descendant of its own
- K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K871027
Methodology: https://510kreport.com/methodology