Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFY · Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
139 daysmedian FDA review time
535 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | 2023-10-27 | 182 | 0 |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | 2015-03-11 | 26 | 0 |
| K070317 | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 2007-07-05 | 153 | 0 |
| K061820 | DIASORIN LIAISON VZV IGG | DiaSorin, Inc. | 2007-02-26 | 243 | 0 |
| K051484 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTE | Zeus Scientific, Inc. | 2005-12-05 | 182 | 0 |
| K984181 | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST | Zeus Scientific, Inc. | 1999-01-22 | 60 | 0 |
| K981867 | IS-VZU IGG TEST SYSTEM | Diamedix Corp. | 1998-09-28 | 123 | 0 |
| K972295 | SERAQUEST VZV IGG | Quest Intl., Inc. | 1997-11-05 | 139 | 0 |
| K961012 | VZV IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1996-07-24 | 133 | 0 |
| K943843 | VARICELISA, MODIFICATION | Biowhittaker Molecular Applications, Inc. | 1996-03-14 | 595 | 0 |
| K941046 | VZV IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-24 | 535 | 0 |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-10-26 | 122 | 1 |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | Pharmacia Diagnostics, Inc. | 1992-01-27 | 140 | 0 |
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | Clinical Sciences, Inc. | 1990-05-15 | 91 | 1 |
| K890642 | VZV MICROASSAY | Diamedix Corp. | 1989-05-15 | 96 | 0 |
| K833637 | VZV BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | 1984-02-10 | 116 | 0 |
| K823805 | VARICELISA TEST KIT | M.A. Bioproducts | 1983-05-05 | 139 | 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