E. HISTOLYTICA II— 510(k) K994101

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K994101 for E. HISTOLYTICA II, Substantially Equivalent on 1999-12-21. 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: 1999-12-06
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Special
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.