K962818 is an FDA 510(k) clearance for the TOBRAMYCIN FLEX REAGENT CARTRIDGE. This device is classified as a Fluorescent Immunoassay, Tobramycin (Class II - Special Controls, product code LCR).
Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on September 13, 1996, 56 days after receiving the submission on July 19, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K962818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | September 13, 1996 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCR — Fluorescent Immunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |