The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for One Step Pregnancy Test.
| Device ID | K936031 |
| 510k Number | K936031 |
| Device Name: | ONE STEP PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K C Chen, Ph.d |
| Correspondent | K C Chen, Ph.d TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-17 |
| Decision Date | 1994-04-15 |