HEMOSAFE— 510(k) K800346

Substantially Equivalent

Med Lab Systems, Inc.

FDA 510(k) clearance K800346 for HEMOSAFE, Substantially Equivalent on 1980-04-16. Applicant: Med Lab Systems, Inc.. Device class: 2.

Clearance details

Applicant: Med Lab Systems, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1980-02-15
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.