Data / Medical devices / United States / Micro Detect, Inc.
Micro Detect, Inc.: FDA-registered device maker in Tustin, CA, United States, 1 510(k) clearance
Micro Detect, Inc. is registered with the FDA (registration 2031341) in Tustin, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 10, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031341
- FEI number
- 3001697474
- Address
- 2852 Walnut Ave., Suite H-1, Tustin, CA, United States, 92780
- Owner or operator
- MICRO DETECT, INC. (9031501)
- Roles
- Manufacturer
- First device listed
- March 19, 1998
- Registered through
- 2026
- Brand names listed
- pylori detect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Helicobacter Pylori | LYR | 1 | 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 |
|---|---|---|---|---|---|---|
| March 10, 1998 | K973508 | PYLORI DETECT IGG | LYR | Substantially Equivalent | Micro Detect, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 10, 1998. 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.