ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)— 510(k) K883883

Name: FDA 510(k) clearance K883883
Creator: U.S. Food and Drug Administration
Published: 1988-10-27

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K883883 for ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS), Substantially Equivalent on 1988-10-27. Applicant: Immco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LKJ
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1988-09-13
Decision date: 1988-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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