SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT— 510(k) K800770

Name: FDA 510(k) clearance K800770
Creator: U.S. Food and Drug Administration
Published: 1980-04-21

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K800770 for SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT, Substantially Equivalent on 1980-04-21. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1980-04-07
Decision date: 1980-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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