Pregnagen(Tm)
FDA 510(k) K884880 · Biogenex Laboratories
510(k) numberK884880
Submission
- Device name
- Pregnagen(Tm)
- Applicant
- Biogenex Laboratories
San Ramon, CA, US - Received
- November 21, 1988
- Decision date
- January 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 |
|---|---|---|
| K012960 | Biogenex Monoclonal Anti-Progesterone ReceptorMXZ · Traditional | 03/08/2002SE |
| K013148 | Biogenex Monoclonal Anti-Estrogen Receptor(Clone ER88)MYA · Traditional | 02/28/2002SE |
| K925189 | Pregnagen 1-STEP Pregnancy TestLCX · Traditional | 01/06/1993SE |
| K902208 | Modified OvugenCEP · Traditional | 07/17/1990SE |
| K882002 | Pregnagen(Tm)JHI · Traditional | 09/09/1988SE |
| K873534 | Ovugen SuretestCEP · Traditional | 11/23/1987SE |
| K831221 | Riagen B-Hcg Ria KitJHI · Traditional | 06/02/1983SE |
| K821657 | Riagen B-Hcg RiaJHI · Traditional | 07/13/1982SE |
| K821234 | Riagen B-Hcg RiaJHI · Traditional | 05/21/1982SE |
| K820724 | Fluorogen Pap FiaJFH · Traditional | 04/14/1982SE |
Questions and answers
When was Pregnagen(Tm) cleared by the FDA?
Pregnagen(Tm) (K884880) received a 510(k) decision of Substantially Equivalent on January 13, 1989, 53 days after the submission was received.
What is the product code of K884880?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.