Beta-Tec
FDA 510(k) K781794 · Wampole Laboratories
510(k) numberK781794
Submission
- Device name
- Beta-Tec
- Applicant
- Wampole Laboratories
Mchenry, IL, US - Received
- October 25, 1978
- Decision date
- December 29, 1978
- 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 |
|---|---|---|
| K965131 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K965129 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 03/26/1997SE |
| K911444 | Rubella Virus Immunological Test SystemLFX · Traditional | 08/30/1991SE |
| K882896 | One-Step HCGDHA · Traditional | 10/31/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | 08/04/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | 03/01/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | 02/17/1988SE |
| K791309 | Ucg-LyphotestJHJ · Traditional | 07/30/1979SE |
| K790986 | RF ControlsDMR · Traditional | 06/28/1979SE |
| K760336 | Biocept-GJHI · Traditional | 11/12/1976SE |
Questions and answers
When was Beta-Tec cleared by the FDA?
Beta-Tec (K781794) received a 510(k) decision of Substantially Equivalent on December 29, 1978, 65 days after the submission was received.
What is the product code of K781794?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.