Osom Card II Hcg-Urine Test, Model 102
FDA 510(k) K990578 · Wyntek Diagnostics, Inc.
510(k) numberK990578
Submission
- Device name
- Osom Card II Hcg-Urine Test, Model 102
- Applicant
- Wyntek Diagnostics, Inc.
San Diego, CA, US - Received
- February 23, 1999
- Decision date
- March 9, 1999
- 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 |
|---|---|---|
| K992658 | Osom Ultra Strep a Test, Model 147GTY · Traditional | 01/18/2000SE |
| K990576 | Osom Card Pregnancy Test, Model 103LCX · Traditional | 03/09/1999SE |
| K974159 | Osom Hcg-Urine Test Model 101JHI · Traditional | 12/24/1997SE |
| K973879 | Osom Card Hcg-Urine TestJHI · Traditional | 11/04/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | 08/26/1997SE |
| K965227 | Osom Classic Hcg-Urine Test (115)JHI · Traditional | 02/04/1997SE |
| K965184 | Perfecta Pregnancy TestLCX · Traditional | 02/04/1997SE |
| K961423 | Osom Strep a TestGTZ · Traditional | 10/11/1996SE |
| K955141 | Osom HCG Combo TestJJX · Traditional | 12/06/1995SE |
| K954178 | Osom Pregnancy TestLCX · Traditional | 10/23/1995SE |
Questions and answers
When was Osom Card II Hcg-Urine Test, Model 102 cleared by the FDA?
Osom Card II Hcg-Urine Test, Model 102 (K990578) received a 510(k) decision of Substantially Equivalent on March 9, 1999, 14 days after the submission was received.
What is the product code of K990578?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.