CREATINE KINASE UV REAGENT SET— 510(k) K905588

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K905588 for CREATINE KINASE UV REAGENT SET, Substantially Equivalent on 1991-01-17. Applicant: Biochemical Trade, Inc.. Device class: 2.

Clearance details

Applicant
Biochemical Trade, Inc.
Product code
Code JHW
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
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