STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT— 510(k) K121046

Name: FDA 510(k) clearance K121046
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Substantially Equivalent

Kronus Market Development Associates, Inc.

FDA 510(k) clearance K121046 for STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT, Substantially Equivalent on 2012-12-20. Applicant: Kronus Market Development Associates, Inc.. Device class: 2.

Clearance details

Applicant: Kronus Market Development Associates, Inc.
Product code: Code PCG
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2012-04-06
Decision date: 2012-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Star, ID, US

Download summary PDF View on FDA.gov ↗

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