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
63 devices
25–48 of 63
Cleared Mar 01, 1990
SPECIMEN CONTAINER
K896794
Westmark, Sterile Packing Systems, Inc. (Sps)
Microbiology · 90d
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 Mar 23, 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 7d
Cleared May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860
Bio-Rad
Microbiology · 16d
Cleared Apr 08, 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 29d
Cleared Aug 04, 1986
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607
Boots-Celltech Diagnostics, Inc.
Microbiology · 27d
Cleared Oct 23, 1984
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935
Syva Co.
Microbiology · 18d
Cleared Mar 19, 1984
SANI CATCH BA
K833814
Concord Laboratories, Inc.
Microbiology · 138d
Cleared Feb 04, 1984
PRESERV SAF FIXATIVE 15ML
K834566
Preventive Diagnostics Corp.
Microbiology · 38d
Cleared Jan 30, 1984
PRESERV MF FIXATIVE 15ML
K840086
Preventive Diagnostics Corp.
Microbiology · 20d
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