510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LOJClass II

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

LOJ is the FDA product code for Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LOJ
Device name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
7

Clearances, product code LOJ

By decision year
17 clearances under product code LOJ with a decision year between 1985 and 2022, 1998 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LOJ by decision year
YearClearances
19851
19972
19984
19991
20023
20082
20092
20222

Applicants with the most clearances

Product code LOJ
Applicants holding the most 510(k) clearances under product code LOJ
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Ortho-Clinical Diagnostics, Inc.2
Roche Diagnostics GmbH2
Bayer Corp.1
Bayer Corp.1
Bayer Diagnostics Corp.1
Beckman Instruments, Inc.1
Boehringer Mannheim Corp.1
Diagnostic Systems Laboratories, Inc.1
Olympus Life Science Research Europa GmbH (Europa)1

Companies listing this code with FDA

Companies whose registered establishments list this code