# K994291: Dimension Special Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 1, 2000 after 71 days
- Product code: JIT (Calibrator, Secondary)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Beckman CAL 1: named in the summary without a submission number

## Indications for use
The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values.

Source page: https://510kreport.com/device/K994291
Methodology: https://510kreport.com/methodology