K781888 is an FDA 510(k) clearance for the ASSAY SYSTEM, FERRITIN I KIT. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on January 10, 1979, 64 days after receiving the submission on November 7, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K781888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1978 |
| Decision Date | January 10, 1979 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |