# K983345: Bayer Immuno 1 System, Upgraded for a Laboratory

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 7, 1998 after 75 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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) Bayer Immuno 1™ System: named in the summary without a submission number

## Indications for use
The Bayer Immuno 1™ System has been upgraded for Laboratory Automation capability. Software and Hardware will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation System (LAS) will coordinate the scheduling, sample identification, and physical transfer of samples, as demonstrated for the following representative methods: CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake.

Source page: https://510kreport.com/device/K983345
Methodology: https://510kreport.com/methodology