The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Fastep Hcg Pregancy Serum/urine Cassette And Dipstick Tests.
| Device ID | K112101 |
| 510k Number | K112101 |
| Device Name: | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2012-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066000274 | K112101 | 000 |
| 00722066000229 | K112101 | 000 |
| 00722066001202 | K112101 | 000 |
| 06952804801847 | K112101 | 000 |
| 00850011007174 | K112101 | 000 |