Hba Sperm-Hyaluronan Binding Assay
FDA 510(k) K032874 · Biocoat, Inc.
510(k) numberK032874
Submission
- Device name
- Hba Sperm-Hyaluronan Binding Assay
- Applicant
- Biocoat, Inc.
Fort Washington, PA, US - Received
- September 15, 2003
- Decision date
- November 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- POV – Semen Analysis Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
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| K241628 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/29/2024SE |
| K220828 | SQA-iO Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems , Ltd. | 08/07/2023SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | Bonraybio Co., Ltd. | 10/28/2020SE |
| K183602 | SwimCount Sperm Quality TestPOV · Traditional | Motilitycount Aps | 06/27/2019SE |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 11/16/2018SE |
| K172514 | Trak Plus Male Fertility Testing SystemPOV · Traditional | Sandstone Diagnostics, Inc. | 11/17/2017SE |
More from Sandstone Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052457 | Picsi Sperm Selection DeviceMQK · Traditional | 04/13/2006SE |
Questions and answers
When was Hba Sperm-Hyaluronan Binding Assay cleared by the FDA?
Hba Sperm-Hyaluronan Binding Assay (K032874) received a 510(k) decision of Substantially Equivalent on November 24, 2003, 70 days after the submission was received.
What is the product code of K032874?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.