Data / Medical devices / Hong Kong / Delta International Trade Asia Pacific Ltd.
Delta International Trade Asia Pacific Ltd.: FDA-registered device maker in Kowloon, Hong Kong, 2 510(k) clearances
Delta International Trade Asia Pacific Ltd. is registered with the FDA (registration 3009526336) in Kowloon, Hong Kong. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009526336
- Address
- 28 Shanghai St. Hang Bong Comm. Ctr. Room 101, Kowloon, Hong Kong, 99999
- Owner or operator
- Delta International Trade Asia Pacific Ltd. (10039497)
- Roles
- Exporter to the US
- First device listed
- January 16, 2012
- Registered through
- 2026
- Brand names listed
- Cooling Relief Sheets, Drug Test Kit, First Aid Bandage, Gauze, LSS, Ovulation Predictor Kit, Pregnancy Test Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Exporter to the US | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Exporter to the US | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Exporter to the US | accessdata.fda.gov |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | 2 | Exporter to the US | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 2, 2015 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | LDJ | Substantially Equivalent | Nantong Egens Biotech Co., Ltd. | accessdata.fda.gov |
| February 5, 2013 | K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | LCX | Substantially Equivalent | Nantong Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of First Aid Kit Without Drug
- All makers of Tape And Bandage, Adhesive
- All makers of Toothbrush, Manual
Updated November 2, 2015. 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.