Atellica IM Total hCG (ThCG)
FDA 510(k) K172322 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK172322
Submission
- Device name
- Atellica IM Total hCG (ThCG)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- August 1, 2017
- Decision date
- March 29, 2018
- 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 |
| 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 |
| K112315 | Home Pregnancy TestJHI · Traditional | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 04/23/2012SE |
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| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
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| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
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| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | 12/04/2024SE |
Questions and answers
When was Atellica IM Total hCG (ThCG) cleared by the FDA?
Atellica IM Total hCG (ThCG) (K172322) received a 510(k) decision of Substantially Equivalent on March 29, 2018, 240 days after the submission was received.
What is the product code of K172322?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.