ACCESS R-CLONE ANA PROFILE ASSAY— 510(k) K885048

Substantially Equivalent

Lipogen, Inc.

FDA 510(k) clearance K885048 for ACCESS R-CLONE ANA PROFILE ASSAY, Substantially Equivalent on 1989-01-24. Applicant: Lipogen, Inc.. Device class: 2.

Clearance details

Applicant: Lipogen, Inc.
Product code: Code DHC
Device class: Class 2
Regulation: 21 CFR 866.5820
Advisory panel: Immunology
Date received: 1988-12-07
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

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