LIO · Class I · 21 CFR 866.2900

FDA Product Code LIO: Device, Specimen Collection

Leading manufacturers include Remel Co., Syva Co. and Bio-Rad.

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 Nov 26, 2001
BACTI-SWAB DRY
K013711
Remel Co.
Microbiology · 19d
Cleared Jun 15, 1993
ZINC PVA
K931383
Remel Co.
Microbiology · 89d
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 Aug 03, 1989
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905
Diagnostic Products Corp.
Microbiology · 65d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342
Bio-Rad
Microbiology · 20d
Cleared May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860
Bio-Rad
Microbiology · 16d
Cleared Oct 23, 1984
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935
Syva Co.
Microbiology · 18d
Cleared Sep 29, 1983
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079
Syva Co.
Microbiology · 93d
Cleared Sep 26, 1983
DUPONT ISOLATOR 1.5 MICROBIAL TUBE
K832246
E.I. Dupont DE Nemours & Co., 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.