PROSTATIC ACID RADIOIMMUNOASSAY TEST— 510(k) K791497

Name: FDA 510(k) clearance K791497
Creator: U.S. Food and Drug Administration
Published: 1979-12-04

Substantially Equivalent

Clinical Assays, Inc.

FDA 510(k) clearance K791497 for PROSTATIC ACID RADIOIMMUNOASSAY TEST, Substantially Equivalent on 1979-12-04. Applicant: Clinical Assays, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Assays, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1979-08-03
Decision date: 1979-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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