# K990554: Dimension Special Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 22, 1999 after 28 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 I: 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 for use in an in vitro test system to establish points of reference that are used in determination of values in the measurement of human substances.

Source page: https://510kreport.com/device/K990554
Methodology: https://510kreport.com/methodology