K843570 is an FDA 510(k) clearance for the FIAX HAPTOGLOBIN TEST KIT. This device is classified as a Haptoglobin, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DAB).
Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984, 24 days after receiving the submission on September 11, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5460.
| 510(k) Number | K843570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1984 |
| Decision Date | October 05, 1984 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAB — Haptoglobin, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5460 |