K821136 is an FDA 510(k) clearance for the TDX TM STREPTOMYCIN. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 13, 1982, 23 days after receiving the submission on April 20, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K821136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1982 |
| Decision Date | May 13, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |