Irradiator for Biological Materials, IBL-137C
FDA 510(k) K865027 · Cis-Us, Inc.
510(k) numberK865027
Submission
- Device name
- Irradiator for Biological Materials, IBL-137C
- Applicant
- Cis-Us, Inc.
Lake Success, NY, US - Received
- December 23, 1986
- Decision date
- February 26, 1987
- 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 |
|---|---|---|
| K951708 | Elsa-HctJKR · Traditional | 09/05/1995SE |
| K950211 | Elsa-PthCEW · Traditional | 04/13/1995SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | 10/27/1989SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | 04/14/1989SE |
| K871502 | Personnel Protective ShieldKPY · Traditional | 05/08/1987SE |
| K863778 | Venticis IIIYT · Traditional | 10/27/1986SE |
| K860823 | Elsa-Prol Immunoradiometric Assay KitCFT · Traditional | 08/19/1986SE |
| K860824 | Tshk-Nn Ria KitJLW · Traditional | 04/28/1986SE |
Questions and answers
When was Irradiator for Biological Materials, IBL-137C cleared by the FDA?
Irradiator for Biological Materials, IBL-137C (K865027) received a 510(k) decision of Substantially Equivalent on February 26, 1987, 65 days after the submission was received.
What is the product code of K865027?
The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.