Aimstep Pregnancy
FDA 510(k) K013857 · Germaine Laboratories, Inc.
510(k) numberK013857
Submission
- Device name
- Aimstep Pregnancy
- Applicant
- Germaine Laboratories, Inc.
San Antonio, TX, US - Received
- November 21, 2001
- Decision date
- January 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | Abbott Laboratories | 06/05/2023SE |
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| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | 10/26/2005SE |
| K991369 | Accudip Home Pregnancy And/Or Aimstick PregnancyLCX · Traditional | 05/10/1999SE |
| K981165 | Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 TestJHI · Traditional | 04/16/1998SE |
| K980531 | Aimstep PregnancyJHI · Traditional | 03/06/1998SE |
| K974512 | Aimstick PBD Combo PregnancyDHA · Traditional | 01/02/1998SE |
| K974368 | Aimstick PBD PregnancyDHA · Traditional | 01/02/1998SE |
| K973825 | Midstream Home Regnancy TestDHA · Traditional | 12/19/1997SE |
Questions and answers
When was Aimstep Pregnancy cleared by the FDA?
Aimstep Pregnancy (K013857) received a 510(k) decision of Substantially Equivalent on January 22, 2002, 62 days after the submission was received.
What is the product code of K013857?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.