# K884125: Bio-Tek Automated Microplate Washer Model EL403

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Dec 2, 1988 after 63 days
- Product code: JTC (Device, Microtiter Diluting/Dispensing)
- Device class: 1
- Regulation: 21 CFR 866.2500
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 20, 2004 · Not classified · Z-0703-05: When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were ad

Source page: https://510kreport.com/device/K884125
Methodology: https://510kreport.com/methodology