Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GQW — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
188 daysmedian FDA review time
378 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICAT | Diagnostic Hybrids, Inc. | 2007-08-30 | 220 | 0 |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSA | Light Diagnostics | 1999-10-19 | 273 | 0 |
| K964872 | VZV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 | 103 | 0 |
| K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Viro Research, Inc. | 1994-12-15 | 188 | 0 |
| K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-11 | 21 | 0 |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Viral Antigens, Inc. | 1990-12-04 | 104 | 0 |
| K894622 | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | 1989-10-24 | 96 | 0 |
| K843676 | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | Zeus Scientific, Inc. | 1985-04-19 | 378 | 0 |
| K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda