K984122 is an FDA 510(k) clearance for the WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR. This device is classified as a Bathophenanthroline, Iron Binding Capacity (Class I - General Controls, product code JQF).
Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 20, 1999, 63 days after receiving the submission on November 18, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K984122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | January 20, 1999 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQF — Bathophenanthroline, Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |