K780182 is an FDA 510(k) clearance for the TOBRAMYCIN 125I RIA KIT. This device is classified as a Bacillus Subtilis Microbiology Assay, Tobramycin (Class II - Special Controls, product code DID).
Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978, 10 days after receiving the submission on February 3, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K780182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1978 |
| Decision Date | February 13, 1978 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DID — Bacillus Subtilis Microbiology Assay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |