FAST HEMOGLOBIN CONTROL-LYOPHILIZED— 510(k) K800794

Name: FDA 510(k) clearance K800794
Creator: U.S. Food and Drug Administration
Published: 1980-04-29

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K800794 for FAST HEMOGLOBIN CONTROL-LYOPHILIZED, Substantially Equivalent on 1980-04-29. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1980-04-09
Decision date: 1980-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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