IN-VITRO TEST DETERMINATION OF SGOT (AST)— 510(k) K854187

Name: FDA 510(k) clearance K854187
Creator: U.S. Food and Drug Administration
Published: 1985-11-25

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K854187 for IN-VITRO TEST DETERMINATION OF SGOT (AST), Substantially Equivalent on 1985-11-25. Applicant: Clinical Data, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Data, Inc.
Product code: Code CIS
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1985-10-15
Decision date: 1985-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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