Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GQO — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
204 daysmedian FDA review time
526 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883281 | VIRGO HSV-2 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 | 219 | 0 |
| K883282 | VIRGO HSV-1 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 | 219 | 0 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-07 | 75 | 1 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | 1988-05-23 | 144 | 0 |
| K871426 | VIROGEN HSV ANTIBODY TEST | Armkel, LLC | 1987-10-15 | 189 | 0 |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Microbiological Research Corp. | 1987-02-02 | 314 | 0 |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | Isolab, Inc. | 1986-05-20 | 179 | 0 |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 | 204 | 0 |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 | 204 | 0 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | 1985-12-06 | 526 | 0 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | 1985-12-06 | 514 | 0 |
| K852931 | HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT | Microbix Biosystems, Inc. | 1985-11-12 | 126 | 0 |
| K841245 | ENZYGNOST ANTIHERPES SIMPLEX VIRUS | Behring Diagnostics, Inc. | 1985-11-05 | 592 | 0 |
| K852928 | VIROGEN HERPES SLIDE TEST | Armkel, LLC | 1985-10-17 | 100 | 0 |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | Scientific Research | 1985-02-26 | 218 | 0 |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | 1979-09-07 | 91 | 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