# K993098: HDL-C/LDL-C Calibrator, Model 1913-003

- Pathway: 510(k) (Traditional)
- Applicant: Data Medical Associates, Inc.
- Decided: Oct 8, 1999 after 22 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) HDL Cholesterol and LDL Cholesterol Calibrator, Reference Diagnostics Inc: named in the summary without a submission number

## Indications for use
For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.

Source page: https://510kreport.com/device/K993098
Methodology: https://510kreport.com/methodology