Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JMG · Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
132 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 | 90 | 0 |
| K052082 | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | 2005-08-19 | 17 | 1 |
| K964282 | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | 1997-07-30 | 275 | 0 |
| K971833 | ELECSYS FERRITIN | Boehringer Mannheim Corp. | 1997-06-02 | 14 | 0 |
| K963498 | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | 1997-01-24 | 143 | 2 |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | 1995-05-16 | 104 | 0 |
| K926221 | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-13 | 34 | 1 |
| K925848 | IMMULITE FERRITIN | Diagnostic Products Corp. | 1993-01-13 | 56 | 0 |
| K920829 | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | 1992-06-19 | 116 | 0 |
| K920318 | CEDIA FERRITIN ASSAY | Microgenics Corp. | 1992-06-04 | 132 | 0 |
| K902997 | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | 1990-08-02 | 31 | 0 |
| K890697 | RIA-GNOST FERRITIN | Cambridge Medical Technology | 1989-03-16 | 34 | 0 |
| K881138 | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | 1988-04-21 | 36 | 0 |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1987-11-04 | 50 | 0 |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | 1987-08-21 | 23 | 0 |
| K840460 | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | 1984-03-30 | 57 | 0 |
| K810799 | QUANTIMUNE FERRITIN IRMA | Bio-Rad | 1981-04-03 | 11 | 0 |
| K792588 | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-01-11 | 25 | 0 |
| K791096 | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | 1979-08-03 | 52 | 0 |
| K782157 | IRMA TEST, NORDICLAB FERRITIN | Nordiclab Intl. | 1979-01-17 | 26 | 0 |
| K781946 | RIA KIT, FERRITIN SOLID PHASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-01-10 | 50 | 0 |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | New England Nuclear | 1979-01-10 | 64 | 0 |
| K781844 | FERRITIN KIT | Ria Products, Inc. | 1979-01-10 | 70 | 0 |
| K781527 | RIA SYSTEM FOR HUMAN FE-RITIN | Calbiochem-Behring Corp. | 1978-10-03 | 28 | 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