Visby Medical, Inc.
San Jose, CA, US
VISBY MEDICAL, INC. appears in FDA device records in San Jose, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Visby Medical, Inc. between 2021 and 2026. The busiest year on record is 2025, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 Test | SIA | Substantially Equivalent | |
| K251501 | Visby Medical Men's Sexual Health Test | QEP | Substantially Equivalent | |
| DEN240020 | Visby Medical Women's Sexual Health Test | SEA | Unknown | |
| K242526 | Visby Medical Respiratory Health Test | QOF | Substantially Equivalent | |
| K220407 | Visby Medical Sexual Health Test | QEP | Substantially Equivalent | |
| K200748 | Visby Medical Sexual Health | QEP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016608638 | 3016608638 | VISBY MEDICAL, INC. | 3010 North First Street, San Jose, CA 95134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia
- LSLDna-Reagents, Neisseria
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- SIAOver-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- SEATest For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0847-2021 | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. | Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain