Midstream Onestep Pregnancy Home Test
FDA 510(k) K963341 · Syntron Bioresearch, Inc.
510(k) numberK963341
Submission
- Device name
- Midstream Onestep Pregnancy Home Test
- Applicant
- Syntron Bioresearch, Inc.
Carlsbad, CA, US - Received
- August 26, 1996
- Decision date
- December 2, 1996
- 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 |
|---|---|---|
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K992990 | Quickpac II One Step Cocaine TestDIO · Traditional | 09/20/1999SE |
| K992748 | Drugcheck X Multidrug Screening DeviceDIO · Traditional | 09/02/1999SE |
| K992207 | Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test SystemDIO · Traditional | 07/22/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | 06/24/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | 11/18/1998SE |
| K981292 | Quikpac II One Step Phencyclidine (PCP) TestLCM · Traditional | 05/26/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | 05/07/1998SE |
| K980349 | Quickpac II One Step Barbiturate TestDIS · Traditional | 03/03/1998SE |
Questions and answers
When was Midstream Onestep Pregnancy Home Test cleared by the FDA?
Midstream Onestep Pregnancy Home Test (K963341) received a 510(k) decision of Substantially Equivalent on December 2, 1996, 98 days after the submission was received.
What is the product code of K963341?
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.