LASER-GLOBIN— 510(k) K850096

Substantially Equivalent

Hematology Marketing Assoc.

FDA 510(k) clearance K850096 for LASER-GLOBIN, Substantially Equivalent on 1985-03-29. Applicant: Hematology Marketing Assoc.. Device class: 2.

Clearance details

Applicant: Hematology Marketing Assoc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1985-01-11
Decision date: 1985-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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