# K961807: Certain HCT Level a & Level B/CVM HCT Levels 1,2,3, & 4

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jul 26, 1996 after 77 days
- Product code: GLK (Control, Hematocrit)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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) GEM critCheck: named in the summary without a submission number

## Indications for use
The intended use Certain® Hct is as a bi-level quality control material and cvm™ is a calibration verification material both for use with hematocrit analyzers.

Source page: https://510kreport.com/device/K961807
Methodology: https://510kreport.com/methodology