The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Monolert* Rapid Elisa Test For Infect. Mono..
| Device ID | K872541 |
| 510k Number | K872541 |
| Device Name: | ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| 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 | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1988-05-13 |