Cleared Traditional

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

K031059 · Ivd Research, Inc. · Microbiology
Jul 2003
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K031059 is an FDA 510(k) clearance for the IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 10, 2003, 104 days after receiving the submission on March 28, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K031059 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2003
Decision Date July 10, 2003
Days to Decision 104 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