FDA product code · Immunology · Class 2
DHB: System, Test, Radioallergosorbent (Rast) Immunological
DHB is FDA's product code for "System, Test, Radioallergosorbent (Rast) Immunological": a Class 2 device classified under 21 CFR 866.5750, reviewed by the Immunology panel.
510(k) review time for DHB
Across 18 510(k) clearances under DHB decided from 2018-01-01 to 2026-10-06, the median was 134 days from FDA receipt to decision. Half took between 89 and 164 days, and 80% were decided within 196 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 89 |
| Median | 134 |
| 75th percentile | 164 |
| 80th percentile | 196 |
| 90th percentile | 284 |
| Slowest | 662 |
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.
DHB in the public FDA record
| 510(k) clearances, all years | 269 |
|---|---|
| Device recalls | 27 |
| Establishment listings | 123 |
| GUDID device identifiers | 919 |
Counts of records, not of devices or events. Adverse event reports for DHB 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 DHB
1 FDA recognized consensus standard cite DHB, among them CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-270 CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) — Analytical Performance Characteristics Quality Assurance and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.