Ameditech Immutest HCG Pregancy Test
FDA 510(k) K023126 · Ameditech, Inc.
510(k) numberK023126
Submission
- Device name
- Ameditech Immutest HCG Pregancy Test
- Applicant
- Ameditech, Inc.
San Diego, CA, US - Received
- September 19, 2002
- Decision date
- November 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup)DIO · Special | 12/05/2011SE |
| K113046 | Ameditech Immutest Milti-Drug ScreenDKZ · Special | 11/10/2011SE |
| K063015 | Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150DJG · Traditional | 12/20/2006SE |
| K053175 | Ameditech DrugsmartcupDKZ · Special | 12/08/2005SE |
| K050186 | Ameditech Immutest Multi-Drug Screen Panel IIIDKZ · Traditional | 03/04/2005SE |
| K042975 | Ameditech Immutest Multi-Drug Screen Panel IIDIS · Traditional | 12/29/2004SE |
| K040092 | Ameditech Immu Test Drug Screen PanelDKZ · Special | 03/08/2004SE |
| K012582 | Ameditech Immutest Drug Screen PCPLCM · Traditional | 11/30/2001SE |
| K012484 | Ameditech Immutest Drug Screen AmphetamineDKZ · Traditional | 11/30/2001SE |
| K012483 | Ameditech Immutest Drug Screen OpiatesDJG · Traditional | 11/30/2001SE |
Questions and answers
When was Ameditech Immutest HCG Pregancy Test cleared by the FDA?
Ameditech Immutest HCG Pregancy Test (K023126) received a 510(k) decision of Substantially Equivalent on November 18, 2002, 60 days after the submission was received.
What is the product code of K023126?
The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.