# K081789: Dimension Clinical Chemistry System Enzyme I Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Sep 10, 2008 after 77 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) Roche Calibrator for automated systems: named in the summary without a submission number

## Indications for use
The ENZ I CAL is an in vitro diagnostic product for the calibration of LDI method on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K081789
Methodology: https://510kreport.com/methodology