DIASCREEN REAGENT STRIPS— 510(k) K981555

Substantially Equivalent

Chronimed, Inc.

FDA 510(k) clearance K981555 for DIASCREEN REAGENT STRIPS, Substantially Equivalent on 1998-06-01. Applicant: Chronimed, Inc.. Device class: 1.

Clearance details

Applicant: Chronimed, Inc.
Product code: Code LJX
Device class: Class 1
Regulation: 21 CFR 864.7675
Advisory panel: Hematology
Date received: 1998-05-01
Decision date: 1998-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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