Data / Medical devices / China / Equinox Biotech Co., Ltd.
Equinox Biotech Co., Ltd.: FDA-registered device maker in Shantou Guangdong, China, 3 510(k) clearances
Equinox Biotech Co., Ltd. is registered with the FDA (registration 3005216656) in Shantou Guangdong, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005216656
- Address
- Rongsheng Technological Zone UNIVERSITY ROAD, Shantou Guangdong, China, 515063
- Owner or operator
- Equinox Biotech Co., Ltd. (9074282)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 25, 2006
- Registered through
- 2026
- Brand names listed
- 6 Days Ahead Pregnancy Test, DAVID ONE STEP OVULATION TEST CASSETTE, DAVID ONE STEP OVULATION TEST MIDSTREAM, DAVID ONE STEP OVULATION TEST STRIP, DAVID OVULATION AND PREGNANCY TEST KIT, DAVID OVULATION TEST KIT, DAVID One Step FSH Urine Test, DAVID One Step Home Use Pregnancy Test Cassette and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 22, 2019 | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette | LCX | Substantially Equivalent | Runbio Biotech Co.,Ltd | accessdata.fda.gov |
| March 28, 2018 | K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | LCX | Substantially Equivalent | Runbio Biotech Co.,Ltd | accessdata.fda.gov |
| July 18, 2006 | K053236 | DAVID PREGNANCY TEST (MIDSTREAM) | LCX | Substantially Equivalent | Runbio Biotech Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated February 22, 2019. 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.