Data / Medical devices / United States / ABOUND Diagnostics, Inc
ABOUND Diagnostics, Inc: FDA-registered device maker in San Diego, CA, United States, 11 510(k) clearances
ABOUND Diagnostics, Inc is registered with the FDA (registration 3030413233) in San Diego, CA, United States. It lists 26 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030413233
- Address
- 12396 World Trade Drive, Suite 216, San Diego, CA, United States, 92128
- Owner or operator
- ABOUND Diagnostics, Inc. (10090000)
- Roles
- Specification developer
- First device listed
- January 17, 2026
- Registered through
- 2026
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 4, 2025 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| February 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| September 27, 2024 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| August 13, 2024 | K241978 | Shinetell Digital Pregnancy Test | LCX | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| June 17, 2024 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| April 5, 2024 | K234152 | ACESO Early Pregnancy Test | LCX | Substantially Equivalent | Aceso Laboratories, Inc. | accessdata.fda.gov |
| December 13, 2023 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | DKZ | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| July 31, 2023 | K231698 | AllTest Fentanyl Rapid Test (Urine) | DJG | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| January 31, 2022 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette | JHI | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| March 27, 2019 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | DKZ | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Barbiturate, Over The Counter
- All makers of Test, Propoxyphene, Over The Counter
- All makers of Test, Phencyclidine (Pcp), Over The Counter
- All makers of Test, Opiates, Over The Counter
Updated April 4, 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.