Acon Quik-Check II Home Pregnancy Test Strip
FDA 510(k) K033041 · ACON Laboratories, Inc.
510(k) numberK033041
Submission
- Device name
- Acon Quik-Check II Home Pregnancy Test Strip
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- September 29, 2003
- Decision date
- November 21, 2003
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid TestSCA · Dual Track | 07/10/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | 11/26/2025SE |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional | 10/22/2025SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | 10/10/2025SE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional | 05/10/2025SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | 05/31/2024SE |
| K233373 | Flowflex® Plus COVID-19 Home TestQYT · Traditional | 04/19/2024SE |
| K230828 | Flowflex COVID-19 Antigen Home TestQYT · Traditional | 11/09/2023SE |
| K193318 | Distinct® Early Detection Pregnancy TestLCX · Traditional | 08/20/2020SE |
| K192175 | On Call Express II Blood Glucose Monitoring SystemNBW · Special | 10/17/2019SE |
Questions and answers
When was Acon Quik-Check II Home Pregnancy Test Strip cleared by the FDA?
Acon Quik-Check II Home Pregnancy Test Strip (K033041) received a 510(k) decision of Substantially Equivalent on November 21, 2003, 53 days after the submission was received.
What is the product code of K033041?
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.