DIASCREEN REAGENT STRIPS— 510(k) K971976

Substantially Equivalent

Dia-Screen Corp.

FDA 510(k) clearance K971976 for DIASCREEN REAGENT STRIPS, Substantially Equivalent on 1997-06-17. Applicant: Dia-Screen Corp.. Device class: 1.

Clearance details

Applicant: Dia-Screen Corp.
Product code: Code LJX
Device class: Class 1
Regulation: 21 CFR 864.7675
Advisory panel: Hematology
Date received: 1997-05-29
Decision date: 1997-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.