Container, Specimen Mailer And Storage, Sterile
FDA product code KDT · Class I (low risk) · 21 CFR 864.3250 · Pathology
12510(k) clearances
0PMA approvals
17recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873593 | Biosure Specimen Collection ContainerKDT · Traditional | Biosure, Inc. | 11/25/1987SE |
| K862665 | Novacyte-UKDT · Traditional | Xsirius Medical, Inc. | 09/04/1986SE |
| K834579 | Biospal 2400SKDT · Traditional | Hospal Medical Corp. | 02/04/1984SE |
| K834412 | Preserv Pva Fixative 15ML-FORMALIN PKKDT · Traditional | Preventive Diagnostics Corp. | 01/13/1984SE |
| K833660 | Preserv Pva Fixative -Malin PackKDT · Traditional | Preventive Diagnostics Corp. | 11/28/1983SE |
| K823773 | Provial II #006-010-0201KDT · Traditional | Dynatech Corp. | 01/21/1983SE |
| K822870 | Stool-Collection/Preservation KitKDT · Traditional | American Scientific Products | 11/01/1982SE |
| K821621 | PregnopostKDT · Traditional | M.M. Wolfred, Ph.D. | 07/21/1982SE |
| K820246 | Prefilled Specimen ContainerKDT · Traditional | Sage Products, Inc. | 02/18/1982SE |
| K811793 | Fix-Right 90ML & 180 ML Prefilled ContKDT · Traditional | Richard-Allan Medical Ind., Inc. | 07/31/1981SE |
| K800946 | Urinary Catheter Sampling KitKDT · Traditional | Sage Products, Inc. | 06/20/1980SE |
| K770071 | Pinlock ContainerKDT · Traditional | Perkins Mfg. Co. | 02/24/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0567-2012 | NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0566-2012 | NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0565-2012 | NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0563-2012 | Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0549-2012 | Medical Mutual Blood Collection Kit, Product K6500, each kit packed in a bag or envelope…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0546-2012 | Heritage Labs Yale Research Kit, Product A2364, 50 kits/shipping carton, each kit packed…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0545-2012 | The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0544-2012 | The National Children's Study Adult Blood Birth Mother Kit/Heritage Labs Westat Birth…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0543-2012 | AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0541-2012 | The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0540-2012 | The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0539-2012 | The National Children's Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0538-2012 | The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0537-2012 | The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0536-2012 | The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0534-2012 | Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |
| Z-0533-2012 | H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25…Kits contain recalled Triad alcohol pads | Heritage Labs International LLC | 01/09/2011Terminated |