CYNOX I HEMOGLOBINOMETER— 510(k) K830569

Name: FDA 510(k) clearance K830569
Creator: U.S. Food and Drug Administration
Published: 1983-04-08

Substantially Equivalent

Buffalo Medical Specialties Mfg., Inc.

FDA 510(k) clearance K830569 for CYNOX I HEMOGLOBINOMETER, Substantially Equivalent on 1983-04-08. Applicant: Buffalo Medical Specialties Mfg., Inc.. Device class: 1.

Clearance details

Applicant: Buffalo Medical Specialties Mfg., Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1983-02-22
Decision date: 1983-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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