SICKLE CELL REAGENT SET— 510(k) K842368

Name: FDA 510(k) clearance K842368
Creator: U.S. Food and Drug Administration
Published: 1984-07-20

Substantially Equivalent

Livonia Diagnostics, Inc.

FDA 510(k) clearance K842368 for SICKLE CELL REAGENT SET, Substantially Equivalent on 1984-07-20. Applicant: Livonia Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Livonia Diagnostics, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1984-06-15
Decision date: 1984-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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