CK-UV REAGENT— 510(k) K823211

Substantially Equivalent

Biorent Diagnostic, Inc.

FDA 510(k) clearance K823211 for CK-UV REAGENT, Substantially Equivalent on 1982-11-22. Applicant: Biorent Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant
Biorent Diagnostic, Inc.
Product code
Code JHS
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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