Data / Medical devices / United States / Syntron Bioresearch, Inc.
Syntron Bioresearch, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 4 510(k) clearances
Syntron Bioresearch, Inc. is registered with the FDA (registration 2025760) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025760
- Address
- 2774 Loker Ave. West, Carlsbad, CA, United States, 92010
- Owner or operator
- SYNTRON BIORESEARCH, INC. (2025760)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- October 8, 2007
- Registered through
- 2026
- Brand names listed
- AFIA Early Result Pregnancy Test, Equate Digital Early Result Pregnancy Test, Equate Early Result Pregnancy Test, First Response Pregnancy Test Cups, Frida Early Detection Pregnancy Test, One Step Menopause Test, Ovulation Test, Frida Baby, SYNTRON QUIKSTRIP/E.Z. STRIP PREGNA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 15, 2019 | K182328 | VeriClear Digital Early Result Pregnancy Test | LCX | Substantially Equivalent | True Diagnostics, Inc. | accessdata.fda.gov |
| December 22, 2017 | K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | JHI | Substantially Equivalent | True Diagnostics, Inc. | accessdata.fda.gov |
| November 8, 1999 | K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 | LCX | Substantially Equivalent | Phamatech | accessdata.fda.gov |
| May 29, 1992 | K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | LCX | Substantially Equivalent | Syntron Bioresearch, Inc. | accessdata.fda.gov |
Compare with other makers
- 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
- All makers of Visual, Pregnancy Hcg, Prescription Use
Updated May 15, 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.