ELIAS ENA SCREEN (MICROTITER PLATE)— 510(k) K940622

Name: FDA 510(k) clearance K940622
Creator: U.S. Food and Drug Administration
Published: 1994-05-11

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K940622 for ELIAS ENA SCREEN (MICROTITER PLATE), Substantially Equivalent on 1994-05-11. Applicant: Elias U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Elias U.S.A., Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-01-18
Decision date: 1994-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osceola, WI, 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.