Cassette/Urine HCG
FDA 510(k) K023638 · Ind Diagnostic, Inc.
510(k) numberK023638
Submission
- Device name
- Cassette/Urine HCG
- Applicant
- Ind Diagnostic, Inc.
Delta, B.C., CA - Received
- October 30, 2002
- Decision date
- January 3, 2003
- 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 |
|---|---|---|
| K103037 | Ind Urinary Tract Infection (Uti) Test StripsNGJ · Traditional | 04/17/2012SE |
| K100031 | Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional | 07/19/2010SE |
| K063390 | Urine Chemistry Analyzer UR-50JIL · Traditional | 03/01/2007SE |
| K060810 | One Step Drug Test - Amp/Met/Mor/Thc/CocDKZ · Traditional | 08/07/2006SE |
| K052694 | One Step HCG Pregnancy Test - 2000 Miu/Ml, Model 100 Series.JHI · Traditional | 12/16/2005SE |
| K052662 | One Step FSH Menopausal TestCGJ · Traditional | 11/30/2005SE |
| K050741 | Ind One Step HCG Pregnancy Test - Cassette FormatJHI · Traditional | 05/16/2005SE |
Questions and answers
When was Cassette/Urine HCG cleared by the FDA?
Cassette/Urine HCG (K023638) received a 510(k) decision of Substantially Equivalent on January 3, 2003, 65 days after the submission was received.
What is the product code of K023638?
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.