FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY— 510(k) K791547

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K791547 for FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY, Substantially Equivalent on 1979-10-12. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1979-08-10
Decision date: 1979-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.