The following data is part of a premarket notification filed by Lehnus & Associates Consulting with the FDA for Pregnancy One Step Rapid Test.
| Device ID | K103574 |
| 510k Number | K103574 |
| Device Name: | PREGNANCY ONE STEP RAPID TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Lehnus & Associates Consulting 150 CHERRY LANE RD. East Stroudsburg, PA 18301 -8804 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus Lehnus & Associates Consulting 150 CHERRY LANE RD. East Stroudsburg, PA 18301 -8804 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850003180189 | K103574 | 000 |
| 10850003180172 | K103574 | 000 |
| 10850003180066 | K103574 | 000 |
| 10810038633272 | K103574 | 000 |
| 10810038633265 | K103574 | 000 |