SICKLE CELL REAGENT SET— 510(k) K860420

Name: FDA 510(k) clearance K860420
Creator: U.S. Food and Drug Administration
Published: 1986-02-24

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860420 for SICKLE CELL REAGENT SET, Substantially Equivalent on 1986-02-24. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1986-02-04
Decision date: 1986-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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