PLA-MATE— 510(k) K803071

Substantially Equivalent

Labex, Inc.

FDA 510(k) clearance K803071 for PLA-MATE, Substantially Equivalent on 1981-07-24. Applicant: Labex, Inc.. Device class: 2.

Clearance details

Applicant: Labex, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1980-12-05
Decision date: 1981-07-24
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.