Panels › Microbiology › Product code LIO · Class 1
Device, Specimen Collection
Regulation 866.2900
0510(k)s in 12 months (63 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in LIO
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel Co. | 5 | 1 |
| Pro-Lab Diagnostics | 4 | 0 |
| Medical Laboratory Automation Systems, Inc. | 3 | 0 |
| Sage Products, Inc. | 3 | 0 |
| Bio-Rad | 2 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 0 |
| Medical Packaging Corp. | 2 | 0 |
| Medical Wire & Equipment Company (Bath), Ltd. | 2 | 0 |
| Ncs Diagnostics, Inc. | 2 | 0 |
| Para Scientific Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2024 | K222613 | ARX Liquid Amies Collection & Transport System Arx Sciences, Inc. | LIO |
| Oct 21, 2013 | K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM Puritan Medical Products, LLC | LIO |
| Jun 8, 2012 | K120846 | TRANSPORT CULTURE MEDIUM DEVICE Puritan Medical Products, LLC | LIO |
| Jan 25, 2011 | K103805 | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE Medical Wire & Equipment Company (Bath), Ltd., GB | LIO |
| Dec 30, 2008 | K082472 | VIROCULT, MODEL MW950 Medical Wire & Equipment Company (Bath), Ltd., GB | LIO |
| Jul 30, 2007 | K070062 | COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE Diesse Diagnostica Senese S.P.A. | LIO |
| Nov 26, 2001 | K013711 | BACTI-SWAB DRY Remel Co. | LIO |
| May 31, 2001 | K003761 | NAT - NUCLEIC ACID TRANSPORT Medical Packaging Corp. | LIO |
| Mar 15, 1999 | K983119 | ENTERO-TEST HP, MODEL #102-01 Hdc Corp. | LIO |
| Jul 14, 1998 | K981391 | PAR-ONE Remel, Inc. | LIO |
| Nov 27, 1996 | K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF Para Scientific Co. | LIO |
| Nov 8, 1996 | K963986 | STP SYSTEM PVA WITH ZINC Sage Products, Inc. | LIO |
| Nov 7, 1996 | K964026 | STP SYSTEM - SAF Sage Products, Inc. | LIO |
| Nov 1, 1996 | K964027 | STP SYSTEM-PVA WITH MERCURY Sage Products, Inc. | LIO |
| Apr 3, 1996 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM Starplex Scientific, Inc., CA | LIO |
| Nov 16, 1995 | K953929 | MID-STREAM COLLECTION SET-STERILE Trinity Laboratories, Inc. | LIO |
| Apr 5, 1995 | K950096 | PINWORM EGG COLLECTOR Evergreen Industries, Inc. | LIO |
| Jun 15, 1993 | K931770 | PARA-PAK PLUS Meridian Diagnostics, Inc. | LIO |
| Jun 15, 1993 | K931383 | ZINC PVA Remel Co. | LIO |
| Mar 18, 1993 | K930313 | APEX SPECIMEN BAG Apex Medical Technologies, Inc. | LIO |
| Jan 15, 1993 | K924053 | CYTOQUANT COMBINED TRANSPORT MEDIA Proteins Intl., Inc. | LIO |
| Dec 24, 1992 | K924331 | TRANSYSTEM LIQUID STUART MEDIUM Pro-Lab Diagnostics, CA | LIO |
| Dec 24, 1992 | K924330 | TRANSYSTEM AMIES WITH CHARCOAL Pro-Lab Diagnostics, CA | LIO |
| Dec 24, 1992 | K924329 | TRANSYSTEM AMIES W/O CHARCOAL Pro-Lab Diagnostics, CA | LIO |
| Dec 24, 1992 | K924328 | TRANSYSTEM LIQUID AMIES MEDIUM Pro-Lab Diagnostics, CA | LIO |
| Jul 30, 1992 | K920536 | AFFIRM VP SAMPLE COLLECTION SET Microprobe Corp. | LIO |
| Jun 19, 1992 | K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE Bio Medicus, Inc. | LIO |
| Apr 8, 1992 | K915454 | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT Medical Packaging Corp. | LIO |
| Aug 22, 1991 | K912832 | BACTI-SWAB(TM) NPG Remel Co. | LIO |
| Jul 30, 1991 | K912831 | BACTI-SWAB(TM) II Remel Co. | LIO |
| Jan 18, 1991 | K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM Medical Laboratory Automation Systems, Inc. | LIO |
| Dec 17, 1990 | K905120 | SAF FIXATIVE Gibson Laboratories, Inc. | LIO |
| Oct 16, 1990 | K903406 | VIRAL ACCU-CULSHURE TM Medical Laboratory Automation Systems, Inc. | LIO |
| Oct 16, 1990 | K903405 | CHLAMYDIA ACCU-CULSHURE TM Medical Laboratory Automation Systems, Inc. | LIO |
| Aug 22, 1990 | K902467 | FLORA-STAT URINE TRANSPORT SYSTEM Wadley Biosciences Corp. | LIO |
| Mar 1, 1990 | K896794 | SPECIMEN CONTAINER Westmark, Sterile Packing Systems, Inc. (Sps) | LIO |
| Feb 2, 1990 | K900225 | ROMCHECK SPECIMEN COLLECTION KIT Adeza Biomedical | LIO |
| Aug 3, 1989 | K893905 | PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) Diagnostic Products Corp. | LIO |
| Apr 21, 1989 | K890134 | FTK FECAL TRANSPORT KIT Evergreen Scientific, Inc. | LIO |
| Nov 3, 1988 | K884342 | NOVAPATH SPECIMEN COLLECTION KIT Bio-Rad | LIO |
| Jul 18, 1988 | K882485 | DIVERSI-KIT Intl. Cancer Screening Laboratories, Inc. | LIO |
| May 13, 1988 | K873565 | SNAP(R) ROTAVIRUS DIAGNOSTIC KIT Molecular Biosystems, Inc. | LIO |
| Mar 23, 1988 | K881125 | PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT Kallestad Diag, A Div. of Erbamont, Inc. | LIO |
| Nov 24, 1987 | K874456 | CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd. | LIO |
| Jul 23, 1987 | K872751 | FLUORTRAN - C(TM) Para Scientific Co. | LIO |
| May 29, 1987 | K871860 | NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT Bio-Rad | LIO |
| Apr 8, 1987 | K870963 | MODIFIED PATHFINDER SPECIMEN COLLECTION KIT Kallestad Diag, A Div. of Erbamont, Inc. | LIO |
| Feb 4, 1987 | K870231 | KULTSURE Ncs Diagnostics, Inc., CA | LIO |
| Jan 5, 1987 | K864727 | CULT-UR R.P. Laboratories, Inc. | LIO |
| Aug 4, 1986 | K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT Boots-Celltech Diagnostics, Inc., GB | LIO |
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