# K093357: Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module Calibrant B, Model ME-5410D

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Jun 24, 2010 after 239 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
Longest line of descent: 1 generation back to K070057 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070057: Easyra Clinical Chemistry Analyzer, Medica Corp. (2007) Summary page 2.

## Indications for use
Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Nat, K+, and Of- electrodes on the Polymnedco Poly-Chem and Randox Daytona instruments having the Medica ISE Module.

Source page: https://510kreport.com/device/K093357
Methodology: https://510kreport.com/methodology