Data / Medical devices / United States / Access Bio, Inc.
Access Bio, Inc.: FDA-registered device maker in Monroe Township, NJ, United States, 2 510(k) clearances
Access Bio, Inc. is registered with the FDA (registration 3024756665) in Monroe Township, NJ, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024756665
- Address
- 7 Fitzgerald Ave, Monroe Township, NJ, United States, 08831
- Owner or operator
- Access Bio, Inc. (10028116)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 16, 2012
- Registered through
- 2026
- Brand names listed
- CareStart COVID-19 Antibody External Controls, CareStart COVID-19 Antigen, CareStart COVID-19 Antigen Home Test, CareStart COVID-19 IgM/IgG, CareStart COVID-19 MDx RT-PCR, CareStart Dengue Combo NS1 & IgM/IgG, CareStart Dengue NS1, CareStart G6PD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | N | Manufacturer | accessdata.fda.gov |
| Dengue Serological Reagents | OSU | 2 | Manufacturer for export | accessdata.fda.gov |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | JBF | 2 | Manufacturer for export | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Covid-19 Antigen Test | QYT | 2 | Manufacturer | accessdata.fda.gov |
| Plasmodium Spp. Detection Reagents | OAX | 2 | Manufacturer for export | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer | accessdata.fda.gov |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | N | Manufacturer | accessdata.fda.gov |
| Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests | QTU | N | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2025 | K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | SCA | Substantially Equivalent | Access Bio, Inc. | accessdata.fda.gov |
| January 29, 2025 | K241915 | CareSuperb COVID-19 Antigen Home Test | QYT | Substantially Equivalent | Access Bio, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Reagents, 2019-Novel Coronavirus Nucleic Acid
- All makers of Plasmodium Spp. Detection Reagents
- All makers of Multi-Analyte Respiratory Virus Antigen Detection Test
- All makers of Coronavirus Antigen Detection Test System.
Updated August 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.