FDA product code · Clinical Chemistry · Class 2
DHA: System, Test, Human Chorionic Gonadotropin
DHA is FDA's product code for "System, Test, Human Chorionic Gonadotropin": a Class 2 device classified under 21 CFR 862.1155, reviewed by the Clinical Chemistry panel.
510(k) review time for DHA
Across 10 510(k) clearances under DHA decided from 2018-01-01 to 2026-10-06, the median was 162 days from FDA receipt to decision. Half took between 78 and 263 days, and 80% were decided within 305 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 78 |
| Median | 162 |
| 75th percentile | 263 |
| 80th percentile | 305 |
| 90th percentile | 383 |
| Slowest | 532 |
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.
DHA in the public FDA record
| 510(k) clearances, all years | 72 |
|---|---|
| Device recalls | 14 |
Counts of records, not of devices or events. Adverse event reports for DHA 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 DHA
No FDA recognized consensus standard cites DHA by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.