Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100
FDA 510(k) K924259 · Medix Biotech, Inc.
510(k) numberK924259
Submission
- Device name
- Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- August 24, 1992
- Decision date
- November 25, 1992
- 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 |
|---|---|---|
| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | 09/08/1995SE |
| K952319 | Contrast & Rapid HCG Urine/Serum TSTJHI · Traditional | 06/20/1995SE |
| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | 07/18/1994SE |
| K932758 | Medix Biotech Bestest Hcg-Urine Test KitJHI · Traditional | 09/28/1993SE |
| K925436 | Medix Biotech Total T3 Enzyme Immunoassay Test KitCDP · Traditional | 12/28/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | 03/18/1992SE |
| K920299 | Medix Biotech Hghenzyme Immunoassay Test KitCFL · Traditional | 03/04/1992SE |
Questions and answers
When was Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100 cleared by the FDA?
Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100 (K924259) received a 510(k) decision of Substantially Equivalent on November 25, 1992, 93 days after the submission was received.
What is the product code of K924259?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.