# K964754: Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine Conjugate

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: Jan 22, 1997 after 56 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.
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) Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE (Phycoerythrin)]: named in the summary without a submission number

## Indications for use
Ortho-mune OKB19A PE Conjugate is intended for use in identification and enumeration of CD19+ human B lymphocytes in whole blood by flow cytometry.

Source page: https://510kreport.com/device/K964754
Methodology: https://510kreport.com/methodology