Data / Medical devices / United States / Kingsway Pharmaceuticals Dba Nfi, LLC
Kingsway Pharmaceuticals Dba Nfi, LLC: FDA-registered device maker in Bristol, TN, United States, 5 510(k) clearances
Kingsway Pharmaceuticals Dba Nfi, LLC is registered with the FDA (registration 3013167221) in Bristol, TN, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013167221
- Address
- 636 Shelby Street Suite 300, Bristol, TN, United States, 37620
- Owner or operator
- Kingsway Pharmaceuticals dba NFI, LLC (10053911)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- September 26, 2025
- Registered through
- 2026
- Brand names listed
- Bikini Zone Ingrown Hair Patch, Equate 6 Days Sooner 50ct Pregnancy Strips, Goodline Ingrown Hair and Nick Patch, SureSign 10Lh + 25mIU Ovulation and Pregnancy Test, SureSign 20ct LH Digital Ovulation Test, SureSign 2ct Menopause (FSH) Test, SureSign 3ct Digital 25mIU Pregnancy Test, SureSign 5ct 10mIU 6 Day Early Pregnancy Test and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 21, 2024 | K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | LCX | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. | accessdata.fda.gov |
| June 16, 2023 | K231045 | Healgen URS Test Strips | LJX | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
| February 28, 2023 | K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | LCX | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. | accessdata.fda.gov |
| November 30, 2022 | K222305 | MissLan Digital Pregnancy Rapid Test | LCX | Substantially Equivalent | Guangzhou Decheng Biotechnology Co., Ltd. | accessdata.fda.gov |
| May 18, 2018 | K180771 | Acro HCG Pregnancy Rapid Test | LCX | Substantially Equivalent | Acro Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Test, Urine Leukocyte
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated June 21, 2024. 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.