# K950568: Ortho-Mune OK-Combo CD3-Fitc/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: May 13, 1996 after 460 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Simultest™ CD3/CD4 (Leu™-4 /3a) (OKT™3 /OKT4A): named in the summary without a submission number

## Most influential descendants
- K951632: Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine) (1997), 0 descendants of its own

## Indications for use
Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry.

Source page: https://510kreport.com/device/K950568
Methodology: https://510kreport.com/methodology