Data / Medical devices / United States / Micro Direct, Inc.
Micro Direct, Inc.: FDA-registered device maker in Lewiston, ME, United States, 1 510(k) clearance
Micro Direct, Inc. is registered with the FDA (registration 1223858) in Lewiston, ME, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 2, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1223858
- FEI number
- 1000305581
- Address
- 803 Webster ST, Lewiston, ME, United States, 04240
- Owner or operator
- MICRO DIRECT, INC. (9007705)
- Roles
- Complaint file establishment
- First device listed
- March 6, 2018
- Registered through
- 2026
- Brand names listed
- CO Check Pro, CO Screen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Gas Chromatograph, Carbon-Monoxide | JKT | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 2, 2018 | K171129 | CO Check Pro, CO Screen | CCJ | Substantially Equivalent | MD Diagnostics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- All makers of Gas Chromatograph, Carbon-Monoxide
Updated March 2, 2018. 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.