HEMOGLOBIN CONTROLS— 510(k) K790457

Name: FDA 510(k) clearance K790457
Creator: U.S. Food and Drug Administration
Published: 1979-04-04

Substantially Equivalent

Data Medical Associates, Inc.

FDA 510(k) clearance K790457 for HEMOGLOBIN CONTROLS, Substantially Equivalent on 1979-04-04. Applicant: Data Medical Associates, Inc.. Device class: 2.

Clearance details

Applicant: Data Medical Associates, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1979-03-05
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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