Container, Specimen Mailer And Storage, Sterile
Regulation 864.3250
0510(k)s in 12 months (12 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in KDT
| Company | 510(k)s | Recalls |
|---|---|---|
| Heritage Labs International LLC | 0 | 17 |
| Preventive Diagnostics Corp. | 2 | 0 |
| Sage Products, Inc. | 2 | 0 |
| American Scientific Products | 1 | 0 |
| Biosure, Inc. | 1 | 0 |
| Dynatech Corp. | 1 | 0 |
| Hospal Medical Corp. | 1 | 0 |
| M.M. Wolfred, Ph.D. | 1 | 0 |
| Perkins Mfg. Co. | 1 | 0 |
| Richard-Allan Medical Ind., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Heritage Labs International LLC NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen coll Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplie Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collection supplie Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen c Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Medical Mutual Blood Collection Kit, Product K6500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood specimen collecti Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Yale Research Kit, Product A2364, 50 kits/shipping carton, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and bl Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, each kit packed in a bag or envelope and contains 2 Triad Medium Alcohol Prep Pads, Cat. No. 10-3001, Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood Birth Mother Kit/Heritage Labs Westat Birth Blood Mother Kit, Product A2357, Kit #BA0121221, each kit packed in a bag or envelope, 25 kits/shipping carton, a Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and subassembly collection packs Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail Collection Kit, Product A2250, Kit #BJ0136829, and Training Kit, Product A2250T, Kit #TJ0000001, each kit packe Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair Collection Kit, Product A2225, Kit #BL1301873, and Training Kit, Product A2225T, Kit #TL0000001, each kit packed Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father Blood Kit, Product A2020, Kit #BA4373185, each kit packed in a bag or envelope, 25 kits/shipping carton, and cont Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother Blood Kit, Product A2015, Kit #BA0146946, each kit packed in a bag or envelope, 25 kits/shipping carton, and cont Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother Blood Kit, Product A2010, Kit #BA0057371, and Training Kit, A2010T, Kit #TA0000151, each kit packed in a bag or e Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC The National Children's Study Adult Blood P1 Mother Kit, Product A2000, Kit #BB5649523, and A2000T (for training), kit #TA0001801, each kit packed in a bag or envelope, 25 kits/shipping carton, each k Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Rules Based Medicine blood collection kit, Product A1777, each kit packed in a box, 12 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, an Terminated |
KDT | None listed |
| Jan 11, 2012 | Heritage Labs International LLC H & W Research Kit, Product A1776, each kit packed in a bag or envelope. 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and blood spe Terminated |
KDT | None listed |
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