# K962499: Zymmune Autoreader-F Fluorescence Microplate Reader

- Pathway: 510(k) (Traditional)
- Applicant: Bartels, Inc.
- Decided: Sep 5, 1996 after 71 days
- Product code: JZT (Fluorometer)
- Device class: 1
- Regulation: 21 CFR 866.4520
- 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) Flow Laboratories Fluoroskan Reader: named in the summary without a submission number

## Indications for use
In combination with approved microplate tests (such as the Bartels manufactured, Zymmune™ CD4/CD8 Cell monitoring assay kit) the Zymmune™ Auto-Reader F [with software] is intended for use for in vitro quantification and monitoring of T-cell levels.

Source page: https://510kreport.com/device/K962499
Methodology: https://510kreport.com/methodology