The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Fastep S10 Hcg Serum/urine Combo Test.
| Device ID | K132834 |
| 510k Number | K132834 |
| Device Name: | FASTEP S10 HCG SERUM/URINE COMBO TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | POLYMED THERAPEUTICS, INC 12828 DOE LANE Gaithersburg, MD 20878 |
| Contact | J.j Xia |
| Correspondent | J.j Xia POLYMED THERAPEUTICS, INC 12828 DOE LANE Gaithersburg, MD 20878 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2014-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066003244 | K132834 | 000 |
| 00722066000267 | K132834 | 000 |
| 00722066000205 | K132834 | 000 |