Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GOL — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
130 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Intl. Diagnostic Technology | 1984-06-07 | 80 | 0 |
| K834032 | RUBAQUICK DIAGNOSTIC KIT | Abbott Laboratories | 1984-04-17 | 147 | 0 |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Calbiochem-Behring Corp. | 1981-03-11 | 34 | 0 |
| K802508 | RUBELISA IGM TEST KIT | M.A. Bioproducts | 1980-12-18 | 64 | 0 |
| K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | Calbiochem-Behring Corp. | 1980-12-18 | 106 | 0 |
| K802339 | EIA RUBELLA-G | Beckman Instruments, Inc. | 1980-12-18 | 83 | 0 |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Clinical Assays, Inc. | 1980-10-23 | 94 | 0 |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | Flow Laboratories, Inc. | 1980-09-16 | 130 | 0 |
| K801507 | ANTIGEN CONTROL CELLS | Ortho Diagnostics, Inc. | 1980-08-20 | 51 | 0 |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-06-30 | 83 | 0 |
| K800797 | MACRO-VUE RUBELLA CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-06-20 | 72 | 0 |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | Intl. Diagnostic Technology | 1980-01-23 | 77 | 0 |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 | 84 | 0 |
| K790976 | RUBAZYME | Abbott Laboratories | 1979-08-16 | 85 | 0 |
| K790212 | CORDIA T | Cordis Corp. | 1979-04-12 | 72 | 0 |
| K780885 | CORDIA R | Cordis Corp. | 1979-01-17 | 236 | 0 |
| K771796 | RUBA-NOST TEST KITS | Behring Diagnostics, Inc. | 1977-10-18 | 25 | 0 |
| K770805 | MEASLES-FA LABELLED (8-441 RF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770809 | MEASLES-FA LABELED PRESERUM (8-441 RNF) | Flow Laboratories, Inc. | 1977-05-20 | 17 | 0 |
| K770092 | HERPESIVIRUS TEST (TYPE L & 2) | Microbiological Research Corp. | 1977-03-01 | 43 | 0 |
| K760889 | TEST FOR DETECTION OF ANTIRUBELLA ANTIB | Abbott Laboratories | 1976-11-16 | 21 | 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