The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Fastep At-home Pregnancy, Hcg, Over The Counter.
| Device ID | K122907 |
| 510k Number | K122907 |
| Device Name: | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B Mission Viejo, CA 92691 |
| Contact | Terri Wallace |
| Correspondent | Terri Wallace POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B Mission Viejo, CA 92691 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10722066005146 | K122907 | 000 |
| 00722066005323 | K122907 | 000 |