Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CGN — Predicate Candidate Screening
64 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
178 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | 2024-06-17 | 266 | 0 |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023-08-23 | 265 | 0 |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020-05-06 | 230 | 0 |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 | 265 | 3 |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazym | Diazyme Laboratories | 2016-11-04 | 142 | 0 |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | 2014-10-17 | 140 | 0 |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | 2011-05-12 | 142 | 0 |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND | Abbott Laboratories | 2010-03-05 | 178 | 0 |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | 2009-10-02 | 149 | 0 |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSIN | Roche Diagnostics Corp. | 2009-06-19 | 308 | 0 |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | 2006-04-21 | 30 | 1 |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | 2005-06-17 | 30 | 0 |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | 2004-12-23 | 21 | 1 |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | 2003-06-25 | 19 | 0 |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 2002-12-16 | 68 | 4 |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | Bayer Diagnostics Corp. | 2001-02-05 | 31 | 14 |
| K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VI | Ortho-Clinical Diagnostics, Inc. | 2000-05-02 | 12 | 1 |
| K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | Diagnostic Products Corp. | 1999-11-12 | 45 | 1 |
| K992365 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1999-08-10 | 26 | 1 |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | 1999-06-30 | 54 | 0 |
| K984166 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VI | Ortho-Clinical Diagnostics, Inc. | 1999-02-05 | 77 | 1 |
| K984301 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 1999-02-05 | 65 | 0 |
| K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 | 84 | 0 |
| K972232 | ABBOTT AXSYM FOLATE | Abbott Laboratories | 1997-06-24 | 8 | 6 |
| K964349 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | 1996-11-27 | 27 | 0 |
| K960800 | CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) | Boehringer Mannheim Corp. | 1996-07-26 | 150 | 0 |
| K955434 | ACCESS FOLATE ASSAY (MODIFICATION) | Beckman Coulter, Inc. | 1996-01-29 | 119 | 0 |
| K954332 | RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-01-24 | 128 | 0 |
| K951155 | CEDIA FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-06-29 | 107 | 0 |
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIA | Miles, Inc. | 1995-05-02 | 97 | 0 |
| K943691 | IMX FOLATE | Abbott Mfg., Inc. | 1995-03-23 | 237 | 5 |
| K944212 | RADIAS RED CELL FOLATE IMMUNOASAY | Bio-Rad | 1995-02-03 | 158 | 0 |
| K946184 | CEDIA(R) FOLATE (NO BOIL) ASSAY | Microgenics Corp. | 1995-01-17 | 28 | 0 |
| K943297 | CIBA CORNING ACS FOLATE ASSAY | Ciba Corning Diagnostics Corp. | 1994-12-12 | 157 | 0 |
| K943705 | FOLIC ACID | Diagnostic Products Corp. | 1994-10-31 | 91 | 1 |
| K943149 | ACCESS RED BLOOD CELL FOLATE ASSAY | Beckman Coulter, Inc. | 1994-08-26 | 57 | 0 |
| K935286 | QUANTAPHASE II B12/FOLATE | Bio-Rad | 1994-02-18 | 137 | 0 |
| K934121 | VISTA FOLATE ASSAY | Syva Co. | 1993-10-22 | 58 | 0 |
| K932887 | ACCESS FOLATE ASSAY | Beckman Coulter, Inc. | 1993-10-12 | 120 | 0 |
| K933571 | RADIAS FOLATE ENZYME IMMUNOASSAY | Bio-Rad | 1993-10-01 | 70 | 0 |
| K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY | Baxter Diagnostics, Inc. | 1992-09-17 | 73 | 0 |
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS | Bio-Rad Laboratories, Inc. | 1992-08-05 | 55 | 16 |
| K921614 | MILENIA FOLIC ACID | Diagnostic Products Corp. | 1992-06-25 | 80 | 0 |
| K921689 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK | Microgenics Corp. | 1992-06-16 | 69 | 0 |
| K893684 | CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1989-07-27 | 72 | 0 |
| K841302 | DIAGNON FOLATE 125I RIA KIT | Diagnon Corp. | 1984-06-22 | 84 | 0 |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Clinical Assays, Inc. | 1983-10-04 | 53 | 0 |
| K822728 | SOLID PHASE SIMUL TRAC VITAMIN B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-11-05 | 58 | 0 |
| K812979 | VITAMIN B12/FOLATE DUAL RADIOASSAY KITS | Amersham Corp. | 1981-11-24 | 32 | 0 |
| K811177 | QUANTA PHASE VITAMIN B-12/FOLATE RAD | Bio-Rad | 1981-05-15 | 17 | 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