Human Chorionic Gonado.-Beta Ria Kit
FDA 510(k) K781310 · Diagnostics Biochem Canada, Inc.
510(k) numberK781310
Submission
- Device name
- Human Chorionic Gonado.-Beta Ria Kit
- Applicant
- Diagnostics Biochem Canada, Inc.
Mchenry, IL, US - Received
- July 31, 1978
- Decision date
- August 31, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K030730 | Free Testosterone Enzymeimmunoassay (Eia) KitCDZ · Traditional | 08/18/2003SE |
| K014120 | Testosterone by Enzymeimmunoassay (Eia)CDZ · Traditional | 02/08/2002SE |
| K864966 | Estrone Analysis Products Radioimmunoassay EstroneCGF · Traditional | 01/09/1987SE |
| K832297 | HYDROXYPROGESTERONE-17JLS · Traditional | 09/01/1983SE |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | 10/31/1980SE |
Questions and answers
When was Human Chorionic Gonado.-Beta Ria Kit cleared by the FDA?
Human Chorionic Gonado.-Beta Ria Kit (K781310) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 31 days after the submission was received.
What is the product code of K781310?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.