ENTAMOEBA TEST— 510(k) K944791

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K944791 for ENTAMOEBA TEST, Substantially Equivalent on 1995-03-09. Applicant: Techlab, Inc.. Device class: 2.

Clearance details

Applicant: Techlab, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1994-09-28
Decision date: 1995-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, 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.