Cleared Traditional

BACTICARD CANDIDA

K935124 · Remel Co. · Microbiology
Feb 1994
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K935124 is an FDA 510(k) clearance for the BACTICARD CANDIDA, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on February 25, 1994, 120 days after receiving the submission on October 28, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K935124 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1993
Decision Date February 25, 1994
Days to Decision 120 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