HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT— 510(k) K970477

Name: FDA 510(k) clearance K970477
Creator: U.S. Food and Drug Administration
Published: 1997-03-10

Substantially Equivalent

Sebia

FDA 510(k) clearance K970477 for HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT, Substantially Equivalent on 1997-03-10. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1997-02-07
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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