One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream
FDA 510(k) K132085 · Co-Innovation Biotech Co., Ltd.
510(k) numberK132085
Submission
- Device name
- One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream
- Applicant
- Co-Innovation Biotech Co., Ltd.
Guangzhou, Guangdong, CN - Received
- July 5, 2013
- Decision date
- November 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
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|---|---|---|
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGL · Traditional | 05/22/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | 03/08/2024SE |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | 01/17/2024SE |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…LCX · Special | 04/05/2022SE |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG · Special | 04/26/2016SE |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardDKZ · Traditional | 12/11/2014SE |
| K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardDJG · Traditional | 08/20/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | 06/16/2014SE |
| K131110 | One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test DipcardDKZ · Traditional | 01/15/2014SE |
Questions and answers
When was One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream cleared by the FDA?
One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream (K132085) received a 510(k) decision of Substantially Equivalent on November 12, 2013, 130 days after the submission was received.
What is the product code of K132085?
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.