K780250 is an FDA 510(k) clearance for the HEMOPEXIN NEPHELOMETRIC ASSAYS. This device is classified as a Hemopexin, Antigen, Antiserum, Control (Class II - Special Controls, product code CZX).
Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978, 14 days after receiving the submission on February 14, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5490.
| 510(k) Number | K780250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1978 |
| Decision Date | February 28, 1978 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CZX — Hemopexin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5490 |