XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01— 510(k) K020595

Name: FDA 510(k) clearance K020595
Creator: U.S. Food and Drug Administration
Published: 2003-02-20

Substantially Equivalent

Xenotope Diagnostics, Inc.

FDA 510(k) clearance K020595 for XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01, Substantially Equivalent on 2003-02-20. Applicant: Xenotope Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Xenotope Diagnostics, Inc.
Product code: Code JWZ
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2002-02-22
Decision date: 2003-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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