HEMOTOLOGY QUALITY CONTROL MIXTURES— 510(k) K810756

Name: FDA 510(k) clearance K810756
Creator: U.S. Food and Drug Administration
Published: 1981-06-30

Substantially Equivalent

Scientific Standards, Inc.

FDA 510(k) clearance K810756 for HEMOTOLOGY QUALITY CONTROL MIXTURES, Substantially Equivalent on 1981-06-30. Applicant: Scientific Standards, Inc.. Device class: 2.

Clearance details

Applicant: Scientific Standards, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1981-03-20
Decision date: 1981-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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