K792013 is an FDA 510(k) clearance for the LANCER L-INA HUMAN REFERENCE SERUM. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 39 days after receiving the submission on October 5, 1979.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K792013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1979 |
| Decision Date | November 13, 1979 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |