CORNING LACTATE DEHYDROPHORETIC ASSAY— 510(k) K841433

Name: FDA 510(k) clearance K841433
Creator: U.S. Food and Drug Administration
Published: 1984-05-16

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K841433 for CORNING LACTATE DEHYDROPHORETIC ASSAY, Substantially Equivalent on 1984-05-16. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1984-04-06
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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