Data / Medical devices / Mexico / Maq-Ops, S. De R.L.
Maq-Ops, S. De R.L.: FDA-registered device maker in Tijuana Baja California, Mexico, 4 510(k) clearances
Maq-Ops, S. De R.L. is registered with the FDA (registration 3017550662) in Tijuana Baja California, Mexico. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 26, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017550662
- Address
- Calle Guerrero Negro 9942 Parque Industrial Pacifico IV, Tijuana Baja California, Mexico, C.P. 22644
- Owner or operator
- ACON Laboratories, Inc. (9063887)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 5, 2020
- Registered through
- 2027
- Brand names listed
- Flowflex COVID-19 Antigen Home Test, Flowflex Plus COVID-19 + Flu A/B Home Test, Flowflex Plus RSV + Flu A/B + COVID Home Test, Flowflex® Plus Strep A Rapid Test Cassette, Flowflex® Plus Strep A Rapid Test Strip, Livongo® Blood Glucose Test Strips, Livongo® Glucose Control Solution, Teladoc Health Blood Glucose Test Strips and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Manufacturer | accessdata.fda.gov |
| Covid-19 Multi-Analyte Antigen Device | QMN | N | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer | accessdata.fda.gov |
| Multi-Analyte Respiratory Virus Antigen Detection Test | SCA | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Covid-19 Antigen Test | QYT | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| November 26, 2025 | K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | GTY | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 22, 2025 | K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | SCA | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| May 10, 2025 | K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | SCA | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| November 9, 2023 | K230828 | Flowflex COVID-19 Antigen Home Test | QYT | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Antigens, All Groups, Streptococcus Spp.
- All makers of Multi-Analyte Respiratory Virus Antigen Detection Test
- All makers of Covid-19 Multi-Analyte Antigen Device
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
Updated November 26, 2025. 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.