FDA Product Code CGN: Acid, Folic, Radioimmunoassay
Leading manufacturers include Beckman Coulter, Inc., Bio-Rad and Abbott Laboratories.
64
Total
64
Cleared
85d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Acid, Folic, Radioimmunoassay Devices (Product Code CGN)
64 devices
Cleared
Jun 17, 2024
Elecsys Folate III
Roche Diagnostics
Chemistry
266d
Cleared
Aug 23, 2023
Access Folate Assay
Beckman Coulter, Inc.
Chemistry
265d
Cleared
May 06, 2020
LIAISON® Folate
DiaSorin, Inc.
Chemistry
230d
Cleared
Apr 12, 2018
Atellica IM Folate Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
265d
Cleared
Nov 04, 2016
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Diazyme Laboratories
Chemistry
142d
Cleared
Oct 17, 2014
ELECSYS FOLATE III
Roche Diagnostics
Chemistry
140d
Cleared
May 12, 2011
ROCHE ELECSYS FOLATE RBC
Roche Diagnostics
Chemistry
142d
Cleared
Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
Abbott Laboratories
Chemistry
178d
Cleared
Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
Roche Diagnostics Corp.
Chemistry
308d
Cleared
Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
Beckman Coulter, Inc.
Chemistry
30d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Roche Diagnostics Corp.
Chemistry
30d
Cleared
Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
21d
Cleared
Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
Roche Diagnostics Corp.
Chemistry
19d
Cleared
Dec 16, 2002
ABBOTT ARCHITECT FOLATE
Abbott Laboratories
Chemistry
68d
Cleared
May 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
Ortho-Clinical Diagnostics, Inc.
Chemistry
12d
Cleared
Nov 12, 1999
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
Diagnostic Products Corp.
Chemistry
45d
Cleared
Aug 10, 1999
AIA-PACK FOLATE ASSAY
Tosoh Medics, Inc.
Chemistry
26d
Cleared
Feb 05, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3
Ortho-Clinical Diagnostics, Inc.
Chemistry
77d
Cleared
Feb 05, 1999
ABBOTT ARCHITECT FOLATE
Abbott Laboratories
Chemistry
65d
Cleared
Jun 24, 1997
ABBOTT AXSYM FOLATE
Abbott Laboratories
Chemistry
8d
Cleared
Nov 27, 1996
AIA-PACK FOLATE ASSAY
Tosoh Medics, Inc.
Chemistry
27d
Cleared
Jul 26, 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
Boehringer Mannheim Corp.
Chemistry
150d
Cleared
Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
Beckman Coulter, Inc.
Chemistry
119d
Cleared
Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Bayer Corp.
Chemistry
128d
About Product Code CGN - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code CGN since 1976, with 64 receiving FDA clearance (average review time: 85 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.