GAMMADAB (125 1) FOLATE RADIOASSAY KIT— 510(k) K791079

Name: FDA 510(k) clearance K791079
Creator: U.S. Food and Drug Administration
Published: 1979-07-17

Substantially Equivalent

Clinical Assays, Inc.

FDA 510(k) clearance K791079 for GAMMADAB (125 1) FOLATE RADIOASSAY KIT, Substantially Equivalent on 1979-07-17. Applicant: Clinical Assays, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Assays, Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1979-06-12
Decision date: 1979-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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