The following data is part of a premarket notification filed by Simplicity Diagnostics, Inc. with the FDA for Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control.
| Device ID | K970100 |
| 510k Number | K970100 |
| Device Name: | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL |
| Classification | Kit, Serological, Positive Control |
| Applicant | SIMPLICITY DIAGNOSTICS, INC. 31 NORTH YORK RD. Hatboro, PA 19040 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman SIMPLICITY DIAGNOSTICS, INC. 31 NORTH YORK RD. Hatboro, PA 19040 |
| Product Code | MJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1997-03-10 |