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

Hepatitis A Test (Antibody And Igm Antibody)

21 CFR 866.3310 / Microbiology
FDA source (opens on fda.gov)

LOL is the FDA product code for Hepatitis A Test (Antibody And Igm Antibody), a class II device type, regulated under 21 CFR 866.3310. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
LOL
Device name
Hepatitis A Test (Antibody And Igm Antibody)
Regulation
21 CFR 866.3310
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
12

Clearances, product code LOL

By decision year
26 clearances under product code LOL with a decision year between 2006 and 2026, 2007 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LOL by decision year
YearClearances
20062
20073
20083
20092
20102
20111
20121
20142
20162
20191
20201
20211
20221
20231
20251
20262

Applicants with the most clearances

Product code LOL
Applicants holding the most 510(k) clearances under product code LOL
ApplicantClearances
Diasorin Inc.8
Siemens Healthcare Diagnostics Inc.5
Bio-Rad Laboratories Inc.4
Abbott Medical3
Roche Diagnostics GmbH3
Ortho-Clinical Diagnostics, Inc.2
Roche Professional Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order