Qupid Plus E.R.
FDA 510(k) K020378 · Stanbio Laboratory
510(k) numberK020378
Submission
- Device name
- Qupid Plus E.R.
- Applicant
- Stanbio Laboratory
Boerne, TX, US - Received
- February 5, 2002
- Decision date
- June 21, 2002
- 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 |
|---|---|---|
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | 06/10/2009SE |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | 07/18/2008SE |
| K050283 | Creatinine LiquicolorJFY · Traditional | 06/30/2005SE |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | 06/30/2005SE |
| K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerJJE · Traditional | 03/14/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | 10/14/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | 10/24/2003SE |
| K974429 | Rapet CRPDCN · Traditional | 02/18/1998SE |
Questions and answers
When was Qupid Plus E.R. cleared by the FDA?
Qupid Plus E.R. (K020378) received a 510(k) decision of Substantially Equivalent on June 21, 2002, 136 days after the submission was received.
What is the product code of K020378?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.