Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST— 510(k) K800769

Name: FDA 510(k) clearance K800769
Creator: U.S. Food and Drug Administration
Published: 1980-04-24

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K800769 for Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST, Substantially Equivalent on 1980-04-24. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1980-04-07
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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