ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT— 510(k) K801771

Name: FDA 510(k) clearance K801771
Creator: U.S. Food and Drug Administration
Published: 1981-01-16

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K801771 for ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT, Substantially Equivalent on 1981-01-16. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code LGL
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1980-07-28
Decision date: 1981-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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