B-CLONE HCG ASSAY— 510(k) K831155

Substantially Equivalent

Monoclonal Antibodies, Inc.

FDA 510(k) clearance K831155 for B-CLONE HCG ASSAY, Substantially Equivalent on 1983-06-02. Applicant: Monoclonal Antibodies, Inc..

Clearance details

Applicant: Monoclonal Antibodies, Inc.
Product code: Code JHJ
Advisory panel: Clinical Chemistry
Date received: 1983-04-08
Decision date: 1983-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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