HEMATOLOGY REFERENCE CONTROLS— 510(k) K772195

Name: FDA 510(k) clearance K772195
Creator: U.S. Food and Drug Administration
Published: 1978-02-03

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K772195 for HEMATOLOGY REFERENCE CONTROLS, Substantially Equivalent on 1978-02-03. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1977-11-28
Decision date: 1978-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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