Cleared Traditional

TRI-COMBO PARASITE SCREEN

K171078 · Techlab, Inc. · Microbiology
Jul 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K171078 is an FDA 510(k) clearance for the TRI-COMBO PARASITE SCREEN, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on July 10, 2017, 90 days after receiving the submission on April 11, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K171078 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2017
Decision Date July 10, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHJ — Cryptosporidium Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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