ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW— 510(k) K820401

Name: FDA 510(k) clearance K820401
Creator: U.S. Food and Drug Administration
Published: 1982-03-15

Substantially Equivalent

Orhto Diagnostic Systems, Inc.

FDA 510(k) clearance K820401 for ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW, Substantially Equivalent on 1982-03-15. Applicant: Orhto Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orhto Diagnostic Systems, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1982-02-12
Decision date: 1982-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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