The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Mono-lex System: Infectious Mononucleosis Latex.
| Device ID | K902541 |
| 510k Number | K902541 |
| Device Name: | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | TRINITY LABORATORIES, INC. 533 PYLON DR. Raleigh, NC 27606 |
| Contact | Bruce A Clinton,phd |
| Correspondent | Bruce A Clinton,phd TRINITY LABORATORIES, INC. 533 PYLON DR. Raleigh, NC 27606 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-06 |
| Decision Date | 1990-06-28 |