Instant-View Pregnancy Urine Mid-Stream Test
FDA 510(k) K984075 · Alfa Scientific Designs, Inc.
510(k) numberK984075
Submission
- Device name
- Instant-View Pregnancy Urine Mid-Stream Test
- Applicant
- Alfa Scientific Designs, Inc.
San Diego, CA, US - Received
- November 16, 1998
- Decision date
- February 16, 1999
- 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 |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
Questions and answers
When was Instant-View Pregnancy Urine Mid-Stream Test cleared by the FDA?
Instant-View Pregnancy Urine Mid-Stream Test (K984075) received a 510(k) decision of Substantially Equivalent on February 16, 1999, 92 days after the submission was received.
What is the product code of K984075?
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.