The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Irradiator For Biological Materials Ibl-437-c.
| Device ID | K851828 |
| 510k Number | K851828 |
| Device Name: | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Product Code | MOT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-09-19 |