TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM— 510(k) K954996

Name: FDA 510(k) clearance K954996
Creator: U.S. Food and Drug Administration
Published: 1996-08-08

Substantially Equivalent

Trend Scientific, Inc.

FDA 510(k) clearance K954996 for TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM, Substantially Equivalent on 1996-08-08. Applicant: Trend Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Trend Scientific, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1995-11-01
Decision date: 1996-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brighton, MN, US

Download summary PDF View on FDA.gov ↗

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