LIO · Class I · 21 CFR 866.2900

FDA Product Code LIO: Device, Specimen Collection

Leading manufacturers include Remel Co., Medical Laboratory Automation Systems, Inc. and Sage Products, Inc..

63
Total
63
Cleared
86d
Avg days
1982
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Device, Specimen Collection Devices (Product Code LIO)

63 devices
1–24 of 63
Cleared Mar 27, 2024
ARX Liquid Amies Collection & Transport System
K222613
Arx Sciences, Inc.
Microbiology · 575d
Cleared Oct 21, 2013
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630
Puritan Medical Products, LLC
Microbiology · 139d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846
Puritan Medical Products, LLC
Microbiology · 80d
Cleared Jan 25, 2011
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
K103805
Medical Wire & Equipment Company (Bath), Ltd.
Microbiology · 28d
Cleared Dec 30, 2008
VIROCULT, MODEL MW950
K082472
Medical Wire & Equipment Company (Bath), Ltd.
Microbiology · 124d
Cleared Jul 30, 2007
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
K070062
Diesse Diagnostica Senese S.P.A.
Microbiology · 206d
Cleared Nov 26, 2001
BACTI-SWAB DRY
K013711
Remel Co.
Microbiology · 19d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761
Medical Packaging Corp.
Microbiology · 176d
Cleared Mar 15, 1999
ENTERO-TEST HP, MODEL #102-01
K983119
Hdc Corp.
Microbiology · 188d
Cleared Jul 14, 1998
PAR-ONE
K981391
Remel, Inc.
Microbiology · 88d
Cleared Nov 27, 1996
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
K964144
Para Scientific Co.
Microbiology · 41d
Cleared Nov 08, 1996
STP SYSTEM PVA WITH ZINC
K963986
Sage Products, Inc.
Microbiology · 35d
Cleared Nov 07, 1996
STP SYSTEM - SAF
K964026
Sage Products, Inc.
Microbiology · 31d
Cleared Nov 01, 1996
STP SYSTEM-PVA WITH MERCURY
K964027
Sage Products, Inc.
Microbiology · 25d
Cleared Apr 03, 1996
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K960997
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Nov 16, 1995
MID-STREAM COLLECTION SET-STERILE
K953929
Trinity Laboratories, Inc.
Microbiology · 87d
Cleared Jun 15, 1993
ZINC PVA
K931383
Remel Co.
Microbiology · 89d
Cleared Jun 15, 1993
PARA-PAK PLUS
K931770
Meridian Diagnostics, Inc.
Microbiology · 67d
Cleared Jan 15, 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053
Proteins Intl., Inc.
Microbiology · 156d
Cleared Aug 22, 1991
BACTI-SWAB(TM) NPG
K912832
Remel Co.
Microbiology · 57d
Cleared Jul 30, 1991
BACTI-SWAB(TM) II
K912831
Remel Co.
Microbiology · 34d
Cleared Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638
Medical Laboratory Automation Systems, Inc.
Microbiology · 158d
Cleared Oct 16, 1990
CHLAMYDIA ACCU-CULSHURE TM
K903405
Medical Laboratory Automation Systems, Inc.
Microbiology · 77d
Cleared Oct 16, 1990
VIRAL ACCU-CULSHURE TM
K903406
Medical Laboratory Automation Systems, Inc.
Microbiology · 77d

About Product Code LIO - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code LIO since 1982, with 63 receiving FDA clearance (average review time: 86 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.