# K093645: Exl Anem Cal, Model RC640

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 5, 2010 after 100 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
Longest line of descent: 5 generations back to K902336 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator, Dade Behring, Inc. (2007) Summary page 1.

## Indications for use
ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(POL) methods on the Dimension(r) EXL(tm) integrated chemistry system and the Ferritin(PERR) method on the Dimension(r) clinical chemistry system.

Source page: https://510kreport.com/device/K093645
Methodology: https://510kreport.com/methodology