Product code LIO— Microbiology
AFFIRM VP SAMPLE COLLECTION SET
- Classification name
- Device, Specimen Collection
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Total cleared
- 63
- First cleared
- Most recent
Market context for product code LIO
FDA has cleared devices under product code LIO between 1982 and 2024, filed by 44 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2024
- 2013
- 2012
- 2011
- 2008
- 2007
- 2001
- 1999
- 1998
- 1996
- 1995
- 1993
- 1992
- 1991
- 1990
Top applicants under product code LIO
Recent clearances under product code LIO
- K222613 — ARX Liquid Amies Collection & Transport System
- K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
- K120846 — TRANSPORT CULTURE MEDIUM DEVICE
- K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
- K082472 — VIROCULT, MODEL MW950
- K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
- K013711 — BACTI-SWAB DRY
- K003761 — NAT - NUCLEIC ACID TRANSPORT
- K983119 — ENTERO-TEST HP, MODEL #102-01
- K981391 — PAR-ONE
- K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
- K963986 — STP SYSTEM PVA WITH ZINC
- K964026 — STP SYSTEM - SAF
- K964027 — STP SYSTEM-PVA WITH MERCURY
- K960997 — STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
- K953929 — MID-STREAM COLLECTION SET-STERILE
- K950096 — PINWORM EGG COLLECTOR
- K931383 — ZINC PVA
- K931770 — PARA-PAK PLUS
- K930313 — APEX SPECIMEN BAG
- K924053 — CYTOQUANT COMBINED TRANSPORT MEDIA
- K924328 — TRANSYSTEM LIQUID AMIES MEDIUM
- K924329 — TRANSYSTEM AMIES W/O CHARCOAL
- K924330 — TRANSYSTEM AMIES WITH CHARCOAL
- K924331 — TRANSYSTEM LIQUID STUART MEDIUM
- K920536 — AFFIRM VP SAMPLE COLLECTION SET
- K920761 — URINE CULTUR STABILIZATION TRANSPORT TUBE
- K915454 — CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
- K912832 — BACTI-SWAB(TM) NPG
- K912831 — BACTI-SWAB(TM) II
- K903638 — GASTRO-INTESTINAL ACCU-CULSHURE TM
- K905120 — SAF FIXATIVE
- K903405 — CHLAMYDIA ACCU-CULSHURE TM
- K903406 — VIRAL ACCU-CULSHURE TM
- K902467 — FLORA-STAT URINE TRANSPORT SYSTEM
- K896794 — SPECIMEN CONTAINER
- K900225 — ROMCHECK SPECIMEN COLLECTION KIT
- K893905 — PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
- K890134 — FTK FECAL TRANSPORT KIT
- K884342 — NOVAPATH SPECIMEN COLLECTION KIT
- K882485 — DIVERSI-KIT
- K873565 — SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
- K881125 — PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
- K874456 — CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
- K872751 — FLUORTRAN - C(TM)
- K871860 — NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
- K870963 — MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
- K870231 — KULTSURE
- K864727 — CULT-UR
- K862607 — IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
- K860655 — KULTSURE (CATALOGUE NO. M200)
- K854719 — LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
- K851378 — VIRTRAN VIRAL TRANPORTER
- K851387 — MICROSTATIC URINE TRANSPORT TUBE FOR C & S
- K843000 — MICRO ORGANISM GROWTH SYS-M1000
- K843935 — MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
- K840799 — V.D.T.-GONORRHEA TEST KIT
- K833814 — SANI CATCH BA
- K834566 — PRESERV SAF FIXATIVE 15ML
- K840086 — PRESERV MF FIXATIVE 15ML
- K832079 — COLLECTION KIT CHLAMYDIA TRACHOMATIS
- K832246 — DUPONT ISOLATOR 1.5 MICROBIAL TUBE
- K820520 — VD ALERT
Data sourced from openFDA. This site is unofficial and independent of the FDA.