SICKLE CELL REAGENT SET— 510(k) K860812

Name: FDA 510(k) clearance K860812
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Michclone Associates, Inc.

FDA 510(k) clearance K860812 for SICKLE CELL REAGENT SET, Substantially Equivalent on 1986-04-11. Applicant: Michclone Associates, Inc.. Device class: 2.

Clearance details

Applicant: Michclone Associates, Inc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1986-03-04
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

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