FDA Product Code LOJ: Kit, Test,alpha-fetoprotein For Testicular Cancer
Leading manufacturers include Dade Behring, Inc., bioMerieux, Inc. and Ortho-Clinical Diagnostics.
17
Total
17
Cleared
135d
Avg days
1985
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Kit, Test,alpha-fetoprotein For Testicular Cancer Devices (Product Code LOJ)
17 devices
Cleared
Sep 15, 2022
Elecsys AFP
Roche Diagnostics
Immunology
237d
Cleared
Jun 15, 2022
VITROS AFP
Ortho-Clinical Diagnostics
Immunology
210d
Cleared
Sep 26, 2008
VIDAS AFP ASSAY
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
Dade Behring, Inc.
Immunology
358d
Cleared
Dec 07, 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
Diagnostic Products Corp.
Immunology
81d
Cleared
May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
Beckman Instruments, Inc.
Immunology
17d
Cleared
Nov 21, 1997
ELECSYS AFP
Boehringer Mannheim Corp.
Immunology
77d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.