The following data is part of a premarket notification filed by Simplicity Diagnostics, Inc. with the FDA for Tech Simple Infectious Mononucleosis Serum Control.
| Device ID | K922726 |
| 510k Number | K922726 |
| Device Name: | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro, PA 19040 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro, PA 19040 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1992-10-05 |