Cleared Traditional

C. ALBICANS PNA FISH

K062461 · Advandx, Inc. · Microbiology
Oct 2006
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K062461 is an FDA 510(k) clearance for the C. ALBICANS PNA FISH, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by Advandx, Inc. (Canton, US). The FDA issued a Cleared decision on October 25, 2006, 63 days after receiving the submission on August 23, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K062461 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2006
Decision Date October 25, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JXB — Kit, Identification, Yeast
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660