Cleared Traditional

IVD CRYPTO/GIARDIA DFA

K024113 · Ivd Research, Inc. · Microbiology
Mar 2003
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K024113 is an FDA 510(k) clearance for the IVD CRYPTO/GIARDIA DFA, a Giardia Spp. (Class II — Special Controls, product code MHI), submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 5, 2003, 82 days after receiving the submission on December 13, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K024113 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2002
Decision Date March 05, 2003
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHI — Giardia Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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