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 6, 1986 | K860655 | KULTSURE (CATALOGUE NO. M200) Ncs Diagnostics, Inc., CA | LIO |
| Feb 24, 1986 | K854719 | LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER) Xsirius Scientific, Inc. | LIO |
| Jun 21, 1985 | K851378 | VIRTRAN VIRAL TRANPORTER Diagnon Corp. | LIO |
| May 20, 1985 | K851387 | MICROSTATIC URINE TRANSPORT TUBE FOR C & S Analytical Luminescence Laboratory, Inc. | LIO |
| Feb 6, 1985 | K843000 | MICRO ORGANISM GROWTH SYS-M1000 Hml Inc/Biotechnology Transfer | LIO |
| Oct 23, 1984 | K843935 | MODIFICATION MICROTRAK DIRECT SPECIMEN TEST Syva Co. | LIO |
| Jun 7, 1984 | K840799 | V.D.T.-GONORRHEA TEST KIT M.G. Laboratories, Inc. | LIO |
| Mar 19, 1984 | K833814 | SANI CATCH BA Concord Laboratories, Inc. | LIO |
| Feb 4, 1984 | K834566 | PRESERV SAF FIXATIVE 15ML Preventive Diagnostics Corp. | LIO |
| Jan 30, 1984 | K840086 | PRESERV MF FIXATIVE 15ML Preventive Diagnostics Corp. | LIO |
| Sep 29, 1983 | K832079 | COLLECTION KIT CHLAMYDIA TRACHOMATIS Syva Co. | LIO |
| Sep 26, 1983 | K832246 | DUPONT ISOLATOR 1.5 MICROBIAL TUBE E.I. Dupont DE Nemours & Co., Inc. | LIO |
| May 14, 1982 | K820520 | VD ALERT Intl. Research Distributors, Inc. | LIO |
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