K842019 is an FDA 510(k) clearance for the TIBC PRETREATMENT KIT. This device is classified as a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I - General Controls, product code JQE).
Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984, 35 days after receiving the submission on May 18, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K842019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1984 |
| Decision Date | June 22, 1984 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQE — Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |