A-GENT QUANTICHROM THROMBIGEN-E— 510(k) K800656

Name: FDA 510(k) clearance K800656
Creator: U.S. Food and Drug Administration
Published: 1980-05-30

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K800656 for A-GENT QUANTICHROM THROMBIGEN-E, Substantially Equivalent on 1980-05-30. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GGQ
Device class: Class 2
Regulation: 21 CFR 864.7720
Advisory panel: Hematology
Date received: 1980-03-25
Decision date: 1980-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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