Cleared Traditional

BACTI-SWAB DRY

K013711 · Remel Co. · Microbiology
Nov 2001
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K013711 is an FDA 510(k) clearance for the BACTI-SWAB DRY, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on November 26, 2001, 19 days after receiving the submission on November 7, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K013711 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2001
Decision Date November 26, 2001
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

Similar Devices — LIO Device, Specimen Collection

All 62
ARX Liquid Amies Collection & Transport System
K222613 · Arx Sciences, Inc. · Mar 2024
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · Puritan Medical Products, LLC · Oct 2013
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · Puritan Medical Products, LLC · Jun 2012
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
K103805 · Medical Wire & Equipment Company (Bath), Ltd. · Jan 2011
VIROCULT, MODEL MW950
K082472 · Medical Wire & Equipment Company (Bath), Ltd. · Dec 2008
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
K070062 · Diesse Diagnostica Senese S.P.A. · Jul 2007