The following data is part of a premarket notification filed by Plantex Usa, Inc. with the FDA for Tpk 1980/1.
| Device ID | K822449 |
| 510k Number | K822449 |
| Device Name: | TPK 1980/1 |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | PLANTEX USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-16 |
| Decision Date | 1982-10-27 |