Ind One Step HCG Pregnancy Test - Cassette Format
FDA 510(k) K050741 · Ind Diagnostic, Inc.
510(k) numberK050741
Submission
- Device name
- Ind One Step HCG Pregnancy Test - Cassette Format
- Applicant
- Ind Diagnostic, Inc.
Delta, B.C., CA - Received
- March 21, 2005
- Decision date
- May 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K103037 | Ind Urinary Tract Infection (Uti) Test StripsNGJ · Traditional | 04/17/2012SE |
| K100031 | Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional | 07/19/2010SE |
| K063390 | Urine Chemistry Analyzer UR-50JIL · Traditional | 03/01/2007SE |
| K060810 | One Step Drug Test - Amp/Met/Mor/Thc/CocDKZ · Traditional | 08/07/2006SE |
| K052694 | One Step HCG Pregnancy Test - 2000 Miu/Ml, Model 100 Series.JHI · Traditional | 12/16/2005SE |
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | 11/30/2005SE |
| K023638 | Cassette/Urine HCGLCX · Traditional | 01/03/2003SE |
Questions and answers
When was Ind One Step HCG Pregnancy Test - Cassette Format cleared by the FDA?
Ind One Step HCG Pregnancy Test - Cassette Format (K050741) received a 510(k) decision of Substantially Equivalent on May 16, 2005, 56 days after the submission was received.
What is the product code of K050741?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.