Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GNP · Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
181 daysmedian FDA review time
520 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | 2002-06-13 | 100 | 0 |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 | 101 | 0 |
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 | 101 | 0 |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 | 270 | 0 |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 | 270 | 0 |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 | 183 | 0 |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Electro-Nucleonics, Inc. | 1989-04-28 | 253 | 0 |
| K884591 | EBV-VCA ANTIBODY (IGG) | Hillcrest Biologicals | 1989-01-24 | 82 | 0 |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 | 181 | 0 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | 1987-06-25 | 79 | 0 |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Microbiological Research Corp. | 1987-02-02 | 314 | 0 |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Granbio, Inc. | 1987-02-02 | 90 | 0 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | 1986-11-28 | 86 | 0 |
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | 1986-04-24 | 190 | 0 |
| K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Biotech Research Laboratories, Inc. | 1986-02-05 | 169 | 0 |
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Amico Lab, Inc. | 1985-12-12 | 520 | 0 |
| K842530 | AMIZYME-EBV TEST KIT | Amico Lab, Inc. | 1985-12-06 | 526 | 0 |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | Electro-Nucleonics Laboratories, Inc. | 1981-05-05 | 36 | 0 |
| K771062 | EBV TEST | Gull Laboratories, Inc. | 1977-07-14 | 31 | 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