# K973050: MICRO21 with WBC Estimate

- Pathway: 510(k) (Traditional)
- Applicant: Triangle Biomedical Sciences, Inc.
- Decided: Nov 7, 1997 after 84 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 its predicate without a number.
- (no number) Manual WBC Estimate: named in the summary without a submission number

## Indications for use
For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.'s MICRO2! with WBC Estimate is a laboratory instrument for locating, digitally storing and displaying white blood cells to aid the technologist in performing the WBC Estimate. Examination and determination of the results must be performed by qualified individuals. INTELLIGENT MEDICAL IMAGING, INC. DOES NOT PROMOTE THE USE OF, PROVIDE SUPPORT FOR, MAKE CLAIMS OF EFFECTIVENESS OF OR ASSUME LIABILITY FOR THIS DEVICE IN ANY OTHER COMMERCIAL, EXPERIMENTAL OR INVESTIGATIONAL APPLICATION. Use of this device in any manner that is inconsistent with its intended use may be in violation of federal law.

Source page: https://510kreport.com/device/K973050
Methodology: https://510kreport.com/methodology