SYPHILIS HEALTH CHECK— 510(k) K102400

Substantially Equivalent

Diagnostics Direct, LLC

FDA 510(k) clearance K102400 for SYPHILIS HEALTH CHECK, Substantially Equivalent on 2011-08-01. Applicant: Diagnostics Direct, LLC. Device class: 2.

Clearance details

Applicant: Diagnostics Direct, LLC
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2010-08-24
Decision date: 2011-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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