FDA.report

510(k) K210933

Device
YSI 2900C Biochemistry Analyzer
Applicant
Ysi, Inc.
510(k) number
K210933
Product code
CGA
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-30
Date received
2021-03-29
Regulation
862.1345
Classification name
Glucose Oxidase, Glucose
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Eric Lute
Address
1725 Brannum Ln. Yellow Springs OH US 45387 45387

FDA Registration Numbers

Source Documents

510(k) summary PDF

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