# K972333: Ammonia/Iron Standard Kit

- Pathway: 510(k) (Traditional)
- Applicant: Verichem Laboratories, Inc.
- Decided: Jul 23, 1997 after 30 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 5 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 20, 2006 · Not classified · Z-0743-2007: Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
- Jun 9, 2006 · Not classified · Z-1547-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st
- Jun 9, 2006 · Not classified · Z-1543-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st
- Jun 9, 2006 · Not classified · Z-1546-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st
- Jun 9, 2006 · Not classified · Z-1548-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st

## Indications for use
The Ammonia/Iron Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K972333
Methodology: https://510kreport.com/methodology