IN-VITRO TEST DETERMINATION OF TOBRAMYCIN— 510(k) K854184

Name: FDA 510(k) clearance K854184
Creator: U.S. Food and Drug Administration
Published: 1985-12-04

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K854184 for IN-VITRO TEST DETERMINATION OF TOBRAMYCIN, Substantially Equivalent on 1985-12-04. Applicant: Clinical Data, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Data, Inc.
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1985-10-15
Decision date: 1985-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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