HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL— 510(k) K893895

Name: FDA 510(k) clearance K893895
Creator: U.S. Food and Drug Administration
Published: 1989-07-25

Substantially Equivalent

Intercare Diagnostics, Inc.

FDA 510(k) clearance K893895 for HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL, Substantially Equivalent on 1989-07-25. Applicant: Intercare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Intercare Diagnostics, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1989-05-30
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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