Irradiator for Biological Materials IBL-437-C
FDA 510(k) K851828 · Syncor Intl. Corp.
510(k) numberK851828
Submission
- Device name
- Irradiator for Biological Materials IBL-437-C
- Applicant
- Syncor Intl. Corp.
Sylmar, CA, US - Received
- April 26, 1985
- Decision date
- September 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MOT – Irradiator, Blood To Prevent Graft Versus Host Disease
- Device class
- Unclassified
Other 510(k)s with product code MOT
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|---|---|---|---|
| K201177 | RadGil2MOT · Traditional | R3 X-Ray L.L.C | 08/17/2020SE |
| K181737 | Raycell MK1MOT · Traditional | Best Theratronics Limited | 01/02/2019SE |
| K172087 | SangrayMOT · Traditional | Hitachi , Ltd. | 10/27/2017SE |
| K161324 | Raycell Mk2MOT · Special | Best Theratronics Limited | 08/12/2016SE |
| K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400MOT · Traditional | Rad Source Technologies, Inc. | 02/17/2009SE |
| K051065 | Raycell X-Ray Blood IrradiatorMOT · Special | Mds Nordion | 05/26/2005SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | Mds Nordion | 05/20/2005SE |
| K032684 | RaycellMOT · Special | Mds Nordion | 09/26/2003SE |
| K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000MOT · Traditional | Rad-Source, Inc. | 03/30/1998SE |
| K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0MOT · Traditional | Nordion International, Inc. | 11/08/1996SE |
More from Nordion International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945825 | Secure Safety InsertFMI · Traditional | 04/10/1995SE |
| K852023 | Cesium 137 Source, CSM-4, CSM-11, CSM-41KXK · Traditional | 08/21/1985SE |
| K850433 | Cesium 137 Endometrial SourceKXK · Traditional | 08/21/1985SE |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | 08/13/1985SE |
| K851033 | Syncortech Chlamydia Direct Speciman KitLJP · Traditional | 06/21/1985SE |
| K844735 | Pth-RiaCEW · Traditional | 04/29/1985SE |
| K850726 | Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional | 03/26/1985SE |
| K850434 | CS137 Sealed SourcesKXK · Traditional | 03/26/1985SE |
| K850208 | Flood Sources & Dose Calibrators W/Various NuclidsIXD · Traditional | 03/26/1985SE |
| K850163 | Iridium 192 WiresIWA · Traditional | 03/26/1985SE |
Questions and answers
When was Irradiator for Biological Materials IBL-437-C cleared by the FDA?
Irradiator for Biological Materials IBL-437-C (K851828) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 146 days after the submission was received.
What is the product code of K851828?
The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.