SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479— 510(k) K924915

Name: FDA 510(k) clearance K924915
Creator: U.S. Food and Drug Administration
Published: 1992-12-18

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K924915 for SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479, Substantially Equivalent on 1992-12-18. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1992-09-29
Decision date: 1992-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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