Cleared Special

CRYPTOSPORIDIUM II

K052932 · Techlab, Inc. · Microbiology
Nov 2005
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K052932 is an FDA 510(k) clearance for the CRYPTOSPORIDIUM II, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 4, 2005, 16 days after receiving the submission on October 19, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K052932 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2005
Decision Date November 04, 2005
Days to Decision 16 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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