# K993606: K-Assay Apo A1/B Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 26, 1999 after 32 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The K-ASSAY Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples.

Source page: https://510kreport.com/device/K993606
Methodology: https://510kreport.com/methodology