FDA product code · Immunology · Class 2
DFH: Kappa, Antigen, Antiserum, Control
DFH is FDA's product code for "Kappa, Antigen, Antiserum, Control": a Class 2 device classified under 21 CFR 866.5550, reviewed by the Immunology panel.
510(k) review time for DFH
Across 14 510(k) clearances under DFH decided from 2018-01-01 to 2026-10-06, the median was 236 days from FDA receipt to decision. Half took between 88 and 418 days, and 80% were decided within 485 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 88 |
| Median | 236 |
| 75th percentile | 418 |
| 80th percentile | 485 |
| 90th percentile | 588 |
| Slowest | 626 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
DFH in the public FDA record
| 510(k) clearances, all years | 63 |
|---|
Counts of records, not of devices or events. Adverse event reports for DFH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite DFH
1 FDA recognized consensus standard cite DFH, among them CLSI I/LA23-A (Replaces I/LA23-P). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-113 CLSI I/LA23-A (Replaces I/LA23-P) — Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme Fluorescence and Luminescence Immunoassays; Approved Guideline
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.