FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY— 510(k) K791596

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K791596 for FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY, Substantially Equivalent on 1979-10-17. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1979-08-15
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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