LOJ · Class II · 21 CFR 866.6010

FDA Product Code LOJ: Kit, Test,alpha-fetoprotein For Testicular Cancer

Leading manufacturers include Bayer Corp., Diagnostic Products Corp. and Diagnostic Systems Laboratories, Inc..

17
Total
17
Cleared
135d
Avg days
1985
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Kit, Test,alpha-fetoprotein For Testicular Cancer Devices (Product Code LOJ)

17 devices
1–17 of 17
Cleared Sep 15, 2022
Elecsys AFP
K220176
Roche Diagnostics
Immunology · 237d
Cleared Jun 15, 2022
VITROS AFP
K213626
Ortho-Clinical Diagnostics
Immunology · 210d
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Sep 26, 2008
VIDAS AFP ASSAY
K080017
bioMerieux, Inc.
Immunology · 267d
Cleared Jun 04, 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597
Dade Behring, Inc.
Immunology · 358d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894
Tosoh Medics, Inc.
Immunology · 25d
Cleared Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807
Bayer Diagnostics Corp.
Immunology · 203d
Cleared Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806
Bayer Corp.
Immunology · 15d
Cleared Jun 21, 1999
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138
Diagnostic Systems Laboratories, Inc.
Immunology · 153d
Cleared Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031
Ortho-Clinical Diagnostics, Inc.
Immunology · 109d
Cleared Dec 07, 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263
Diagnostic Products Corp.
Immunology · 81d
Cleared May 01, 1998
ELECSYS AFP
K981282
Roche Diagnostics GmbH
Immunology · 23d
Cleared May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354
Beckman Instruments, Inc.
Immunology · 17d
Cleared Nov 21, 1997
ELECSYS AFP
K973351
Boehringer Mannheim Corp.
Immunology · 77d
Cleared Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972462
Bayer Corp.
Immunology · 83d

About Product Code LOJ - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code LOJ since 1985, with 17 receiving FDA clearance (average review time: 135 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.