Data / Medical devices / United States / LKC Technologies, Inc.
LKC Technologies, Inc.: FDA-registered device maker in Germantown, MD, United States, 2 510(k) clearances
LKC Technologies, Inc. is registered with the FDA (registration 1119189) in Germantown, MD, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 19, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1119189
- Address
- 20501 Seneca Meadows Pkwy Ste 305, Germantown, MD, United States, 20876
- Owner or operator
- LKC TECHNOLOGIES, INC. (1119189)
- Roles
- Manufacturer
- First device listed
- June 25, 1992
- Registered through
- 2027
- Brand names listed
- CMGS-1, EPIC, EPIC-4000, MGS-2, RETeval; RETeval Complete; RETeval Flicker; RETeval Sensor Strips, SG-2002, UTAS, UTAS BigShot and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 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 |
|---|---|---|---|---|---|---|
| May 19, 2015 | K142567 | RETeval Visual Electrodiagnostic Device | GWE | Substantially Equivalent | Lkc Technologies, Inc. | accessdata.fda.gov |
| March 4, 1982 | K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | GWF | Substantially Equivalent | Lkc Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Stimulator, Photic, Evoked Response
Updated May 19, 2015. 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.