The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Result Plus/rubella Rapid Color. Immunoassay.
| Device ID | K884617 |
| 510k Number | K884617 |
| Device Name: | ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Contact | Patricia Bonness |
| Correspondent | Patricia Bonness ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 Raritan, NJ 08869 -0606 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-02-02 |