SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE— 510(k) K062681

Name: FDA 510(k) clearance K062681
Creator: U.S. Food and Drug Administration
Published: 2006-10-13

Substantially Equivalent

Trek Diagnostic Systems, Ltd.

FDA 510(k) clearance K062681 for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE, Substantially Equivalent on 2006-10-13. Applicant: Trek Diagnostic Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Trek Diagnostic Systems, Ltd.
Product code: Code JWY
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2006-09-08
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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