SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)— 510(k) K961043

Name: FDA 510(k) clearance K961043
Creator: U.S. Food and Drug Administration
Published: 1996-05-06

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K961043 for SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY), Substantially Equivalent on 1996-05-06. Applicant: Scantibodies Laboratory, Inc.. Device class: 2.

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
Advisory panel: Clinical Chemistry
Date received: 1996-03-14
Decision date: 1996-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, CA, US

Download summary PDF View on FDA.gov ↗

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