FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
FDA 510(k) clearance K112101 · decided 2012-07-17
Clearance details
- K-number
- K112101
- Device name
- FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
- Applicant
- Polymed Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-22
- Decision date
- 2012-07-17
- Days to decision
- 361 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mission Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Innovita HCG Pregnancy Rapid Combo Test (K241919) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| Alltest Pregnancy Rapid Combo Test Cassette (K203272) | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| Atellica IM Total hCG (ThCG) (K172322) | Siemens Healthcare Diagnostics, Inc. | 2018-03-29 |
| TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) (K172257) | True Diagnostics, Inc. | 2017-12-22 |
| Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768) | Assure Tech. Co., Ltd. | 2016-02-24 |
| WUNDER PREGNANCY TEST (K130456) | James Nguyen | 2014-04-08 |
| FASTEP S10 HCG SERUM/URINE COMBO TEST (K132834) | Polymed Therapeutics, Inc. | 2014-01-09 |
| SOFIA(R) HCG FIA (K131166) | Quidel Corp. | 2013-08-02 |
| CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST (K123844) | Chemtron Biotech, Inc. | 2013-05-30 |
| HOME PREGNANCY TEST (K112315) | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| RAPIDVUE HCG TEST (K102175) | Quidel Corporation | 2010-08-25 |
| FASTPACK HCG IMMUNOASSAY (K072264) | Qualigen, Inc. | 2007-12-06 |
Recalls involving this device
No recalls on record reference this clearance.