# K983469: Preciset Serum Proteins Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 25, 1998 after 55 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) C.f.a.s. Protein Calibrator: named in the summary without a submission number

## Most influential descendants
- K984425: Modification of Preciset Serum Proteins Calibrator (1999), 0 descendants of its own

## Indications for use
For calibration of immunoturbidimetric assays on BM/Hitachi systems

Source page: https://510kreport.com/device/K983469
Methodology: https://510kreport.com/methodology