# K971470: MICRO21 with Cerebrospinal Fluid

- Pathway: 510(k) (Traditional)
- Applicant: Triangle Biomedical Sciences, Inc.
- Decided: Sep 16, 1997 after 147 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
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 no predicate by number.

## Indications for use
Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.

Source page: https://510kreport.com/device/K971470
Methodology: https://510kreport.com/methodology