K800868 is an FDA 510(k) clearance for the FERRO-QUANT TM FE 59 TEST KIT. This device is classified as a Radiometric, Fe59, Iron Binding Capacity (Class I - General Controls, product code JQG).
Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980, 12 days after receiving the submission on April 17, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K800868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1980 |
| Decision Date | April 29, 1980 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQG — Radiometric, Fe59, Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |