Atlas FDA

LIO

63 FDA 510(k) clearances · Product code

77 daysmedian time to decision
176 days90th percentile
63clearances measured

FDA profile

Official device name
Device, Specimen Collection
Device class
Class I (low risk)
Regulation
21 CFR 866.2900
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 8 · 2008: 5 · 2009: 3 · 2010: 4 · 2014: 7 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ARX Liquid Amies Collection & Transport System (K222613)Arx Sciences, Inc.2024-03-27
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (K131630)Puritan Medical Products, LLC2013-10-21
TRANSPORT CULTURE MEDIUM DEVICE (K120846)Puritan Medical Products, LLC2012-06-08
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE (K103805)Medical Wire & Equipment Company (Bath), Ltd.2011-01-25
VIROCULT, MODEL MW950 (K082472)Medical Wire & Equipment Company (Bath), Ltd.2008-12-30
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE (K070062)Diesse Diagnostica Senese S.P.A.2007-07-30
BACTI-SWAB DRY (K013711)Remel Co.2001-11-26
NAT - NUCLEIC ACID TRANSPORT (K003761)Medical Packaging Corp.2001-05-31
ENTERO-TEST HP, MODEL #102-01 (K983119)Hdc Corp.1999-03-15
PAR-ONE (K981391)Remel, Inc.1998-07-14
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF (K964144)Para Scientific Co.1996-11-27
STP SYSTEM PVA WITH ZINC (K963986)Sage Products, Inc.1996-11-08
STP SYSTEM - SAF (K964026)Sage Products, Inc.1996-11-07
STP SYSTEM-PVA WITH MERCURY (K964027)Sage Products, Inc.1996-11-01
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K960997)Starplex Scientific, Inc.1996-04-03
MID-STREAM COLLECTION SET-STERILE (K953929)Trinity Laboratories, Inc.1995-11-16
PINWORM EGG COLLECTOR (K950096)Evergreen Industries, Inc.1995-04-05
ZINC PVA (K931383)Remel Co.1993-06-15
PARA-PAK PLUS (K931770)Meridian Diagnostics, Inc.1993-06-15
APEX SPECIMEN BAG (K930313)Apex Medical Technologies, Inc.1993-03-18
CYTOQUANT COMBINED TRANSPORT MEDIA (K924053)Proteins Intl., Inc.1993-01-15
TRANSYSTEM LIQUID STUART MEDIUM (K924331)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM AMIES WITH CHARCOAL (K924330)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM LIQUID AMIES MEDIUM (K924328)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM AMIES W/O CHARCOAL (K924329)Pro-Lab Diagnostics1992-12-24
AFFIRM VP SAMPLE COLLECTION SET (K920536)Microprobe Corp.1992-07-30
URINE CULTUR STABILIZATION TRANSPORT TUBE (K920761)Bio Medicus, Inc.1992-06-19
CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (K915454)Medical Packaging Corp.1992-04-08
BACTI-SWAB(TM) NPG (K912832)Remel Co.1991-08-22
BACTI-SWAB(TM) II (K912831)Remel Co.1991-07-30
GASTRO-INTESTINAL ACCU-CULSHURE TM (K903638)Medical Laboratory Automation Systems, Inc.1991-01-18
SAF FIXATIVE (K905120)Gibson Laboratories, Inc.1990-12-17
VIRAL ACCU-CULSHURE TM (K903406)Medical Laboratory Automation Systems, Inc.1990-10-16
CHLAMYDIA ACCU-CULSHURE TM (K903405)Medical Laboratory Automation Systems, Inc.1990-10-16
FLORA-STAT URINE TRANSPORT SYSTEM (K902467)Wadley Biosciences Corp.1990-08-22
SPECIMEN CONTAINER (K896794)Westmark, Sterile Packing Systems, Inc. (Sps)1990-03-01
ROMCHECK SPECIMEN COLLECTION KIT (K900225)Adeza Biomedical1990-02-02
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) (K893905)Diagnostic Products Corp.1989-08-03
FTK FECAL TRANSPORT KIT (K890134)Evergreen Scientific, Inc.1989-04-21
NOVAPATH SPECIMEN COLLECTION KIT (K884342)Bio-Rad1988-11-03
DIVERSI-KIT (K882485)Intl. Cancer Screening Laboratories, Inc.1988-07-18
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (K873565)Molecular Biosystems, Inc.1988-05-13
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT (K881125)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-23
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT (K874456)Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.1987-11-24
FLUORTRAN - C(TM) (K872751)Para Scientific Co.1987-07-23
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT (K871860)Bio-Rad1987-05-29
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT (K870963)Kallestad Diag, A Div. of Erbamont, Inc.1987-04-08
KULTSURE (K870231)Ncs Diagnostics, Inc.1987-02-04
CULT-UR (K864727)R.P. Laboratories, Inc.1987-01-05
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K862607)Boots-Celltech Diagnostics, Inc.1986-08-04
KULTSURE (CATALOGUE NO. M200) (K860655)Ncs Diagnostics, Inc.1986-03-06
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER) (K854719)Xsirius Scientific, Inc.1986-02-24
VIRTRAN VIRAL TRANPORTER (K851378)Diagnon Corp.1985-06-21
MICROSTATIC URINE TRANSPORT TUBE FOR C & S (K851387)Analytical Luminescence Laboratory, Inc.1985-05-20
MICRO ORGANISM GROWTH SYS-M1000 (K843000)Hml Inc/Biotechnology Transfer1985-02-06
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST (K843935)Syva Co.1984-10-23
V.D.T.-GONORRHEA TEST KIT (K840799)M.G. Laboratories, Inc.1984-06-07
SANI CATCH BA (K833814)Concord Laboratories, Inc.1984-03-19
PRESERV SAF FIXATIVE 15ML (K834566)Preventive Diagnostics Corp.1984-02-04
PRESERV MF FIXATIVE 15ML (K840086)Preventive Diagnostics Corp.1984-01-30
COLLECTION KIT CHLAMYDIA TRACHOMATIS (K832079)Syva Co.1983-09-29
DUPONT ISOLATOR 1.5 MICROBIAL TUBE (K832246)E.I. Dupont DE Nemours & Co., Inc.1983-09-26
VD ALERT (K820520)Intl. Research Distributors, Inc.1982-05-14

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Every clearance here is in the API, with alerts when new ones post.