FDA product code · Clinical Toxicology · Class 2
DKZ: Enzyme Immunoassay, Amphetamine
DKZ is FDA's product code for "Enzyme Immunoassay, Amphetamine": a Class 2 device classified under 21 CFR 862.3100, reviewed by the Clinical Toxicology panel.
510(k) review time for DKZ
Across 10 510(k) clearances under DKZ decided from 2018-01-01 to 2026-10-06, the median was 145 days from FDA receipt to decision. Half took between 84 and 220 days, and 80% were decided within 237 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 84 |
| Median | 145 |
| 75th percentile | 220 |
| 80th percentile | 237 |
| 90th percentile | 256 |
| Slowest | 264 |
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.
DKZ in the public FDA record
| 510(k) clearances, all years | 225 |
|---|---|
| Device recalls | 24 |
| Establishment listings | 301 |
| GUDID device identifiers | 4,008 |
Counts of records, not of devices or events. Adverse event reports for DKZ 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 DKZ
No FDA recognized consensus standard cites DKZ 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.