# K984193: Dimensions RXL Myoglobin (Myo) Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 14, 1998 after 21 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Dade Behring Stratus® Myoglobin Calibrator: named in the summary without a submission number

## Most influential descendants
- K122599: Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator (2012), 0 descendants of its own
- K053576: Dimension Vista Myo Reagent Cartridge and Calibrator (2006), 0 descendants of its own

## Indications for use
The Dimension® RxL Myoglobin (MYO) Calibrator is intended to be used to calibrate the Myoglobin Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Source page: https://510kreport.com/device/K984193
Methodology: https://510kreport.com/methodology