XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03— 510(k) K020226

Name: FDA 510(k) clearance K020226
Creator: U.S. Food and Drug Administration
Published: 2002-08-22

Substantially Equivalent

Hellen Professional Services

FDA 510(k) clearance K020226 for XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03, Substantially Equivalent on 2002-08-22. Applicant: Hellen Professional Services. Device class: 1.

Clearance details

Applicant: Hellen Professional Services
Product code: Code JWZ
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2002-01-22
Decision date: 2002-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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