ANTINUCLEAR ANTOBODY CELL SUBSTRATE— 510(k) K822607

Name: FDA 510(k) clearance K822607
Creator: U.S. Food and Drug Administration
Published: 1982-09-17

Substantially Equivalent

Immulok, Inc.

FDA 510(k) clearance K822607 for ANTINUCLEAR ANTOBODY CELL SUBSTRATE, Substantially Equivalent on 1982-09-17. Applicant: Immulok, Inc.. Device class: 2.

Clearance details

Applicant: Immulok, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1982-08-27
Decision date: 1982-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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