# K970921: Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)

- Pathway: 510(k) (Traditional)
- Applicant: Alko Diagnostic Corp.
- Decided: Apr 8, 1997 after 27 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
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) Dade Dimension Chemistry System product SS40 (MultiPLY Standard A): named in the summary without a submission number
- (no number) Dade Dimension Chemistry System product SS550 (MultiPLY Standard B): named in the summary without a submission number
- (no number) Dade Dimension Chemistry System product S560 (MultiPLY Standard C): named in the summary without a submission number

## Indications for use
The A,B,C Standards are intended for use in calibrating Na+, K+, Cl- and TCO2 analytes on the Dade Dimension Chemistry Systems.

Source page: https://510kreport.com/device/K970921
Methodology: https://510kreport.com/methodology