HYDRAGEL PROTEIN(E) KIT— 510(k) K951536

Substantially Equivalent

Sebia

FDA 510(k) clearance K951536 for HYDRAGEL PROTEIN(E) KIT, Substantially Equivalent on 1995-06-30. Applicant: Sebia. Device class: 1.

Clearance details

Applicant: Sebia
Product code: Code CEF
Device class: Class 1
Regulation: 21 CFR 862.1630
Advisory panel: Clinical Chemistry
Date received: 1995-04-03
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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