The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for Hcg Pregnancy One Step Test Strip.
| Device ID | K934830 |
| 510k Number | K934830 |
| Device Name: | HCG PREGNANCY ONE STEP TEST STRIP |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 -8726 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 -8726 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1993-12-02 |