SICKLE-HEME A/S HETEROZYGOUS CONTROL— 510(k) K842955

Name: FDA 510(k) clearance K842955
Creator: U.S. Food and Drug Administration
Published: 1984-08-09

Substantially Equivalent

Michclone Associates, Inc.

FDA 510(k) clearance K842955 for SICKLE-HEME A/S HETEROZYGOUS CONTROL, Substantially Equivalent on 1984-08-09. 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: 1984-07-27
Decision date: 1984-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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