Cleared Traditional

STP SYSTEM-PVA WITH MERCURY

K964027 · Sage Products, Inc. · Microbiology
Nov 1996
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K964027 is an FDA 510(k) clearance for the STP SYSTEM-PVA WITH MERCURY, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on November 1, 1996, 25 days after receiving the submission on October 7, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K964027 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1996
Decision Date November 01, 1996
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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