FDA Product Code CGN: Acid, Folic, Radioimmunoassay
Leading manufacturers include Bio-Rad, Abbott Laboratories and Beckman Coulter, Inc..
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
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
Nov 12, 1999
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
Diagnostic Products Corp.
Chemistry
45d
Cleared
Feb 05, 1999
ABBOTT ARCHITECT FOLATE
Abbott Laboratories
Chemistry
65d
Cleared
Jun 24, 1997
ABBOTT AXSYM FOLATE
Abbott Laboratories
Chemistry
8d
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
Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
Bio-Rad
Chemistry
158d
Cleared
Oct 31, 1994
FOLIC ACID
Diagnostic Products Corp.
Chemistry
91d
Cleared
Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
Beckman Coulter, Inc.
Immunology
57d
Cleared
Feb 18, 1994
QUANTAPHASE II B12/FOLATE
Bio-Rad
Chemistry
137d
Cleared
Oct 22, 1993
VISTA FOLATE ASSAY
Syva Co.
Chemistry
58d
Cleared
Oct 12, 1993
ACCESS FOLATE ASSAY
Beckman Coulter, Inc.
Immunology
120d
Cleared
Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
Bio-Rad
Chemistry
70d
Cleared
Jun 25, 1992
MILENIA FOLIC ACID
Diagnostic Products Corp.
Chemistry
80d
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.