The following data is part of a premarket notification filed by New England Nuclear with the FDA for Tobramycin 125i Ria Kit.
| Device ID | K780182 |
| 510k Number | K780182 |
| Device Name: | TOBRAMYCIN 125I RIA KIT |
| Classification | Bacillus Subtilis Microbiology Assay, Tobramycin |
| Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DID |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-03 |
| Decision Date | 1978-02-13 |