The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Ptk Plus. Home Pregnancy Test.
| Device ID | K861946 |
| 510k Number | K861946 |
| Device Name: | PTK PLUS. HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Contact | Balzer, Jr |
| Correspondent | Balzer, Jr HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-16 |