Precise TM HCG for Use in the Physicians Office la
FDA 510(k) K915200 · Becton Dickinson Advanced Diagnostics
510(k) numberK915200
Submission
- Device name
- Precise TM HCG for Use in the Physicians Office la
- Applicant
- Becton Dickinson Advanced Diagnostics
Cockeysville, MD, US - Received
- November 19, 1991
- Decision date
- December 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K935667 | Qtest(R) StrepGTY · Traditional | 04/21/1994SE |
| K931294 | Iq Tuptake AssayKHQ · Traditional | 07/22/1993SE |
| K931295 | Iq TT4 AssayCDX · Traditional | 07/20/1993SE |
| K926356 | Precise(Tm) Hcg(Urine/Serum) and Prcise(Tm) PregJHI · Traditional | 03/18/1993SE |
| K925132 | Becton Dickinson Thyroid Stimulating Hormone SysteJLW · Traditional | 12/28/1992SE |
| K923673 | Precise Strep aGTZ · Traditional | 09/28/1992SE |
| K923060 | Iq Immunochemistry Sistem; Iq TSH AssayJJE · Traditional | 09/15/1992SE |
| K914958 | Riatrac PlusJJY · Traditional | 03/18/1992SE |
| K915197 | Precise TM HCGJHI · Traditional | 12/17/1991SE |
Questions and answers
When was Precise TM HCG for Use in the Physicians Office la cleared by the FDA?
Precise TM HCG for Use in the Physicians Office la (K915200) received a 510(k) decision of Substantially Equivalent on December 16, 1991, 27 days after the submission was received.
What is the product code of K915200?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.