# K960776: MICRO21 with Retic

- Pathway: 510(k) (Traditional)
- Applicant: Triangle Biomedical Sciences, Inc.
- Decided: May 17, 1996 after 81 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
The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.

Source page: https://510kreport.com/device/K960776
Methodology: https://510kreport.com/methodology