Clearview HCG Serum/Urine
FDA 510(k) K905741 · Unipath , Ltd.
510(k) numberK905741
Submission
- Device name
- Clearview HCG Serum/Urine
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- December 24, 1990
- Decision date
- May 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHI – Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional | Innovita (Tangshan) Biological Technology Co.… | 08/02/2024SE |
| K203272 | Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 01/31/2022SE |
| K172322 | Atellica IM Total hCG (ThCG)JHI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/29/2018SE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional | True Diagnostics, Inc. | 12/22/2017SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | Assure Tech. Co., Ltd. | 02/24/2016SE |
| K130456 | Wunder Pregnancy TestJHI · Traditional | James Nguyen | 04/08/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | Polymed Therapeutics, Inc. | 01/09/2014SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | Quidel Corp. | 08/02/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | Chemtron Biotech, Inc. | 05/30/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | Polymed Therapeutics, Inc. | 07/17/2012SE |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061769 | E.P.T. Certainty 1-STEP Pregnancy TestLCX · Special | 07/03/2006SE |
| K060128 | Clearblue Easy Digital Pregnancy TestLCX · Traditional | 05/25/2006SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | 12/06/2005SE |
| K050930 | E.P.T. Certainty Pregnancy TestLCX · Special | 05/12/2005SE |
| K042280 | Fact Plus One-Step Pregnancy Test KitLCX · Special | 09/10/2004SE |
| K041404 | Clearblue Easy Easy Read Pregnancy TestLCX · Special | 06/08/2004SE |
| K040341 | Clearblue Easy Earliest Results Pregnancy TestLCX · Special | 03/08/2004SE |
| K040329 | Modification to E.P.T. Pregnancy TestLCX · Special | 03/08/2004SE |
| K033658 | E.P.T. Pregnancy TestLCX · Special | 01/16/2004SE |
| K032939 | Ept Certainty Pregnancy TestLCX · Special | 10/20/2003SE |
Questions and answers
When was Clearview HCG Serum/Urine cleared by the FDA?
Clearview HCG Serum/Urine (K905741) received a 510(k) decision of Substantially Equivalent on May 15, 1991, 142 days after the submission was received.
What is the product code of K905741?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.