ALPHA-THAL SCREEN TM CONTROL— 510(k) K810976

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K810976 for ALPHA-THAL SCREEN TM CONTROL, Substantially Equivalent on 1981-05-29. 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: 1981-04-10
Decision date: 1981-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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