Cards O.S. (TM) Hcg-Urine
FDA 510(k) K895390 · Pacific Biotech, Inc.
510(k) numberK895390
Submission
- Device name
- Cards O.S. (TM) Hcg-Urine
- Applicant
- Pacific Biotech, Inc.
San Diego, CA, US - Received
- August 30, 1989
- Decision date
- November 13, 1989
- 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 |
|---|---|---|
| K924461 | Strep a Negative ControlGTZ · Traditional | 12/02/1993SE |
| K902510 | Cards O.S. MonoKTN · Traditional | 07/16/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | 03/06/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | 12/13/1989SE |
| K891770 | HCG Irma IIJHI · Traditional | 05/24/1989SE |
| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
| K883742 | Modified TSH Irma KitJLW · Traditional | 01/03/1989SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | 11/18/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | 10/12/1988SE |
| K883639 | Modified HCG Irma KitJHI · Traditional | 10/06/1988SE |
Questions and answers
When was Cards O.S. (TM) Hcg-Urine cleared by the FDA?
Cards O.S. (TM) Hcg-Urine (K895390) received a 510(k) decision of Substantially Equivalent on November 13, 1989, 75 days after the submission was received.
What is the product code of K895390?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.