Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJB — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
152 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Diamedix Corp. | 1998-01-28 | 55 | 1 |
| K971620 | QUANTA LITE RUBEOLA (MEASLES) IGG | Inova Diagnostics, Inc. | 1997-07-22 | 82 | 0 |
| K922335 | BARTELS RUBEOLA IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 | 112 | 0 |
| K922330 | BARTELS RUBEOLA IGG EIA | Baxter Diagnostics, Inc. | 1992-09-02 | 112 | 0 |
| K910290 | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | Virus Reference Laboratory, Inc. | 1992-03-18 | 421 | 0 |
| K904083 | RUBEOLA IGM ELISA TEST | Gull Laboratories, Inc. | 1991-01-03 | 120 | 0 |
| K903961 | MEASLES IGG MICROASSAY | Diamedix Corp. | 1990-12-28 | 122 | 0 |
| K904854 | RUBEOLA IGG ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 | 36 | 0 |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Clinical Sciences, Inc. | 1989-06-15 | 79 | 0 |
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 | 152 | 0 |
| K821762 | MEASELISA TEST KIT | M.A. Bioproducts | 1982-07-30 | 45 | 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