# K960774: MICRO21 with Ana

- Pathway: 510(k) (Traditional)
- Applicant: Triangle Biomedical Sciences, Inc.
- Decided: May 22, 1996 after 86 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925670 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925670: IMS-200, Intelligent Medica Imaging, Inc. (1993) Summary page 1.

## Indications for use
location, storage and display of ANA images to aid the technologist in performing the ANA Test Screen

Source page: https://510kreport.com/device/K960774
Methodology: https://510kreport.com/methodology