The following data is part of a premarket notification filed by Biocoat, Inc. with the FDA for Hba Sperm-hyaluronan Binding Assay.
| Device ID | K032874 |
| 510k Number | K032874 |
| Device Name: | HBA SPERM-HYALURONAN BINDING ASSAY |
| Classification | Semen Analysis Device |
| Applicant | BIOCOAT, INC. 455 PENNSYLVANIA AVE. Fort Washington, PA 19034 |
| Contact | James B Johnston |
| Correspondent | James B Johnston BIOCOAT, INC. 455 PENNSYLVANIA AVE. Fort Washington, PA 19034 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-11-24 |