Sure Check Pregnancy Test
FDA 510(k) K011551 · Chembio Diagnostic Systems, Inc.
510(k) numberK011551
Submission
- Device name
- Sure Check Pregnancy Test
- Applicant
- Chembio Diagnostic Systems, Inc.
Beverly, MA, US - Received
- May 18, 2001
- Decision date
- August 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO · Traditional | 06/03/2020SE |
| K011550 | HCG Stat Pak Ultra-FastJHI · Special | 08/14/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | 05/02/2001SE |
| K981913 | Prevue(Tm) Borrelia Burgdorferi Antibody Detection AssayLSR · Traditional | 02/12/1999SE |
| K961965 | Sure Check Pregnancy TestLCX · Traditional | 06/24/1996SE |
| K923925 | HCG Stat-PakJHI · Traditional | 12/24/1992SE |
Questions and answers
When was Sure Check Pregnancy Test cleared by the FDA?
Sure Check Pregnancy Test (K011551) received a 510(k) decision of Substantially Equivalent on August 14, 2001, 88 days after the submission was received.
What is the product code of K011551?
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.