The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho-mune Okb (cd19)- Monoclonal Antibody (murine) Phycoerythrine Conjugate.
| Device ID | K964754 |
| 510k Number | K964754 |
| Device Name: | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE |
| Classification | Counter, Differential Cell |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Joanne Harris |
| Correspondent | Joanne Harris ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-01-22 |
| Summary: | summary |