Data / Medical devices / Mexico / Biomerica De Mexico, S.A. De C.V.
Biomerica De Mexico, S.A. De C.V.: FDA-registered device maker in MEXICALI Baja California, Mexico, 3 510(k) clearances
Biomerica De Mexico, S.A. De C.V. is registered with the FDA (registration 3004569406) in MEXICALI Baja California, Mexico. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2001. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004569406
- Address
- Saturno 20-A Parque Industrial Mexicali 1, MEXICALI Baja California, Mexico, 21210
- Owner or operator
- Biomerica, Inc. (2016793)
- Roles
- Manufacturer
- First device listed
- November 22, 1985
- Registered through
- 2027
- Brand names listed
- Aware Breast Pad, C. difficile (GDH), EZ HCG, FORTEL OVULATION, Fortel Microalbumin Screening, Giardia Lateral Flow Rapid Test, LH Lateral Flow Rapid Test, Listeria Lateral Flow Rapid Test and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, C. Difficile | MCB | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Listeria Monocytogenes | GSH | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Shigella Spp. | GNB | 2 | Manufacturer | accessdata.fda.gov |
| Giardia Spp. | MHI | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | 1 | 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 21, 2001 | K003856 | EZ-HCG URINE(PREGNANCY TEST) | JHI | Substantially Equivalent | Biomerica, Inc. | accessdata.fda.gov |
| July 20, 1999 | K991469 | AWARE PAD | IYO | Substantially Equivalent | Aac Consulting Group, Inc. | accessdata.fda.gov |
| April 7, 1986 | K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | KHE | Substantially Equivalent | Self Care Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- All makers of Visual, Pregnancy Hcg, Prescription Use
- All makers of Antisera, All Types, Listeria Monocytogenes
- All makers of Giardia Spp.
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Radioimmunoassay, Luteinizing Hormone
Updated February 21, 2001. 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.