ML24199A174
| ML24199A174 | |
| Person / Time | |
|---|---|
| Issue date: | 07/23/2024 |
| From: | Sida B NRC/NMSS/DMSST/MSLB |
| To: | Woods B ABK Biomedical |
| References | |
| 24-09 | |
| Download: ML24199A174 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
July 23, 2024
Ms. Brandi Woods Director Regulatory Affairs ABK Biomedical, Inc.
1513 Research Park Drive Columbia, MO 65211
SUBJECT:
ABK BIOMEDICAL, INCORPORATED AMENDED SEALED SOURCE AND DEVICE REGISTRATION CERTIFICATE NR-1513-D-101-S
Dear Ms. Woods:
This letter is in response to your application dated February 29, 2024, requesting an amendment to your sealed source and devic e registration certificate NR-1513-D-101-S to include Model Eye90 microspheres Gen II. We have completed our review of your request, and a copy of the registration certificate NR-1513-D-101-S is enclosed.
Please be advised that you must manufacture and distribute any registered product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. A registration certificate is meant to indicate that your pr oduct is acceptable for licensing purposes but does not authorize distribution or possession of radioactive material. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in it s entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing if you decide to no longer manufacture, distribute, or offer service support for the product.
B. Woods 2
If you have any questions, please contact me at Brenda.Sida@nrc.gov.
Sincerely, 7/23/2024
X Br enda S i da
S i gned by : Br enda J. S i da Materials Safety and Licensing Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Registration Certificate NR-1513-D-101-S
ML24199A174 OFC NMSS/MSLB NMSS/MSLB NMSS/MSLB NMSS/MSLB NAME CTyler BSida LSepulveda JRolland DATE 7/17/2024 7/22/2024 7/22/2024 7/23/2024