K003341 is an FDA 510(k) clearance for the EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS. This device is classified as a Radioimmunoassay, Tobramycin (Class II - Special Controls, product code KLB).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on January 22, 2001, 89 days after receiving the submission on October 25, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K003341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2000 |
| Decision Date | January 22, 2001 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KLB — Radioimmunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |