RHEUMELISA II SCL-70 ANTIBODY TEST KIT— 510(k) K930130

Name: FDA 510(k) clearance K930130
Creator: U.S. Food and Drug Administration
Published: 1993-03-23

Substantially Equivalent

Biowhittaker Molecular Applications, Inc.

FDA 510(k) clearance K930130 for RHEUMELISA II SCL-70 ANTIBODY TEST KIT, Substantially Equivalent on 1993-03-23. Applicant: Biowhittaker Molecular Applications, Inc.. Device class: 2.

Clearance details

Applicant: Biowhittaker Molecular Applications, Inc.
Product code: Product code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1993-01-12
Decision date: 1993-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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