Data / Medical devices / United States / Ysi Incorporated
Ysi Incorporated: FDA-registered device maker in Yellow Spgs, OH, United States, 1 510(k) clearance
Ysi Incorporated is registered with the FDA (registration 1550101) in Yellow Spgs, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1550101
- Address
- 1700 Brannum Ln 1725 Brannum Ln, Yellow Spgs, OH, United States, 45387
- Owner or operator
- YSI INCORPORATED (1550101)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 29, 1977
- Registered through
- 2026
- Brand names listed
- 2323C GLUCOSE/LACTATE KIT PLUS, 2324C GLUCOSE STARTER KIT PLUS, 2325C LACTATE STARTER KIT PLUS, 2900C BIOCHEMISTRY ANALYZER, YSI 2900C BIOCHEMISTRY ANALYZER
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Lactic, Enzymatic Method | KHP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Analyzer, Enzyme, For Clinical Use | JJI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 30, 2024 | K210933 | YSI 2900C Biochemistry Analyzer | CGA | Substantially Equivalent | Ysi, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Acid, Lactic, Enzymatic Method
- All makers of Glucose Oxidase, Glucose
- All makers of Analyzer, Enzyme, For Clinical Use
Updated September 30, 2024. 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.