K810086 is an FDA 510(k) clearance for the IRON & TICB. This device is classified as a Bathophenanthroline, Iron Binding Capacity (Class I - General Controls, product code JQF).
Submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 15 days after receiving the submission on January 13, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1415.
| 510(k) Number | K810086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1981 |
| Decision Date | January 28, 1981 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQF — Bathophenanthroline, Iron Binding Capacity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1415 |