ULTRACLONE ECL-01-600 CELL LINE— 510(k) K841338

Name: FDA 510(k) clearance K841338
Creator: U.S. Food and Drug Administration
Published: 1984-05-11

Substantially Equivalent

Earl-Clay Laboratories, Inc.

FDA 510(k) clearance K841338 for ULTRACLONE ECL-01-600 CELL LINE, Substantially Equivalent on 1984-05-11. Applicant: Earl-Clay Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Earl-Clay Laboratories, Inc.
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1984-04-02
Decision date: 1984-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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