EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS— 510(k) K003341

Name: FDA 510(k) clearance K003341
Creator: U.S. Food and Drug Administration
Published: 2001-01-22

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K003341 for EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS, Substantially Equivalent on 2001-01-22. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 2000-10-25
Decision date: 2001-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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