The following data is part of a premarket notification filed by Hedeco with the FDA for Pem-t.
| Device ID | K830497 |
| 510k Number | K830497 |
| Device Name: | PEM-T |
| Classification | Kit, Screening, Trichomonas |
| Applicant | HEDECO 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-16 |
| Decision Date | 1983-04-05 |