PTK Plus. Home Pregnancy Test
FDA 510(k) K861946 · Healthcheck Corp.
510(k) numberK861946
Submission
- Device name
- PTK Plus. Home Pregnancy Test
- Applicant
- Healthcheck Corp.
Cheshire, CT, US - Received
- May 20, 1986
- Decision date
- June 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K884489 | C&T Pregnancy Test KitLCX · Traditional | 03/08/1989SE |
| K874818 | TenstarGZJ · Traditional | 09/28/1988SE |
| K881003 | Digital Blood Pressure Monitor Model CX-1DXN · Traditional | 05/18/1988SE |
| K863181 | Healthcheck Therm-StripFQZ · Traditional | 09/11/1986SE |
| K860287 | Pulsonic Digital Blood Pressure Monitor Model BP-3DXN · Traditional | 04/28/1986SE |
| K851379 | Healthcheck Digital Thermometer Model 1 TH-2FLL · Traditional | 04/12/1985SE |
| K850070 | Healthcheck Auto Inflate Digital BP Monitor BP-2DXN · Traditional | 01/22/1985SE |
| K844281 | PTK Healthcheck Pregnancy Test KitLCX · Traditional | 12/10/1984SE |
Questions and answers
When was PTK Plus. Home Pregnancy Test cleared by the FDA?
PTK Plus. Home Pregnancy Test (K861946) received a 510(k) decision of Substantially Equivalent on June 16, 1986, 27 days after the submission was received.
What is the product code of K861946?
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.