FDA product code · Hematology · Class 2
GKZ: Counter, Differential Cell
GKZ is FDA's product code for "Counter, Differential Cell": a Class 2 device classified under 21 CFR 864.5220, reviewed by the Hematology panel.
510(k) review time for GKZ
Across 27 510(k) clearances under GKZ decided from 2018-01-01 to 2026-10-06, the median was 244 days from FDA receipt to decision. Half took between 157 and 328 days, and 80% were decided within 354 days. These are past clearances, not a forecast for a new submission.
| Fastest | 32 |
|---|---|
| 25th percentile | 157 |
| Median | 244 |
| 75th percentile | 328 |
| 80th percentile | 354 |
| 90th percentile | 510 |
| Slowest | 722 |
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.
GKZ in the public FDA record
| 510(k) clearances, all years | 380 |
|---|---|
| Device recalls | 244 |
| Establishment listings | 422 |
| GUDID device identifiers | 442 |
Counts of records, not of devices or events. Adverse event reports for GKZ 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 GKZ
6 FDA recognized consensus standards cite GKZ, 1 of them recognized only in part, among them CLSI H42-A2 (Replaces H42-A); CLSI H43-A2; CLSI H56-A (Replaces H56-P). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-145 CLSI H42-A2 (Replaces H42-A) — Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
- 7-150 CLSI H43-A2 — Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
- 7-163 CLSI H56-A (Replaces H56-P) — Body Fluid Analysis for Cellular Composition; Approved Guideline.
- 7-165 CLSI H20-A2 (Replaces H20-A) — Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
- 7-210 CLSI H26-A2 (partial recognition) — Validation Verification and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
- 7-277 CLSI GP41 7th Edition — Collection of Diagnostic Venous Blood Specimens
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.