K990216 is an FDA 510(k) clearance for the MAGNETIC TIBC KIT. This device is classified as a Ferrozine (colorimetric) Iron Binding Capacity (Class I - General Controls, product code JMO).
Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on February 16, 1999, 25 days after receiving the submission on January 22, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K990216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1999 |
| Decision Date | February 16, 1999 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMO — Ferrozine (colorimetric) Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |