Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GQH — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
233 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | Intracel Corp. | 1998-12-14 | 166 | 0 |
| K964875 | CMV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 | 103 | 0 |
| K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1994-05-05 | 154 | 0 |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Stellar Bio Systems, Inc. | 1988-12-05 | 150 | 0 |
| K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG | Whittaker Bioproducts, Inc. | 1988-08-03 | 78 | 0 |
| K881932 | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT | Ortho Diagnostic Systems, Inc. | 1988-08-01 | 83 | 0 |
| K880679 | BION CMV-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-03 | 105 | 1 |
| K880290 | MICROTRAK CMV CULTURE CONFIRMATION TEST | Syva Co. | 1988-04-19 | 85 | 0 |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | Enzo Biochem, Inc. | 1987-12-04 | 157 | 0 |
| K873114 | CYTOMEGALOVIRUS CONTROL SLIDES | Medical Diagnostic Technologies, Inc. | 1987-09-25 | 46 | 0 |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | Serono Diagnostics, Inc. | 1987-02-19 | 92 | 0 |
| K843657 | CYTOMEGALOVIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | Clinical Sciences, Inc. | 1984-05-02 | 233 | 0 |
| K811671 | CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-09-16 | 93 | 0 |
| K802930 | CYTOMEGALO VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1981-01-09 | 51 | 0 |
| K801963 | CMV TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-23 | 65 | 0 |
| K801722 | CMV BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-09-16 | 55 | 0 |
| K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS | Intl. Diagnostic Technology | 1979-11-16 | 46 | 0 |
| K791612 | CMV BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 | 84 | 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