CHROMOSTREAK— 510(k) K000718

Substantially Equivalent

Novamed , Ltd.

FDA 510(k) clearance K000718 for CHROMOSTREAK, Substantially Equivalent on 2000-08-24. Applicant: Novamed , Ltd.. Device class: 1.

Clearance details

Applicant: Novamed , Ltd.
Product code: Code JSN
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2000-03-03
Decision date: 2000-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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