The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho-mune Ok-combo Cd3-fitc/cd19-pe (okt3/okb19a Monolclonal Antibody (murine).
| Device ID | K951100 |
| 510k Number | K951100 |
| Device Name: | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) |
| Classification | Counter, Differential Cell |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patrick A Roche |
| Correspondent | Patrick A Roche 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 | 1995-03-10 |
| Decision Date | 1996-05-13 |