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

Extractable Antinuclear Antibody, Antigen And Control

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

LLL is the FDA product code for Extractable Antinuclear Antibody, Antigen And Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 182 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LLL
Device name
Extractable Antinuclear Antibody, Antigen And Control
Regulation
21 CFR 866.5100
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
182
Ingested recalls
4

Clearances, product code LLL

By decision year
182 clearances under product code LLL with a decision year between 1981 and 2026, 1993 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code LLL by decision year
YearClearances
19811
19831
19842
19852
19864
19872
19888
19896
19909
19915
199219
199320
199412
199510
199610
199714
199813
19995
20009
20014
20034
20042
20052
20061
20081
20101
20111
20132
20153
20162
20181
20191
20231
20252
20262

Applicants with the most clearances

Product code LLL
Applicants holding the most 510(k) clearances under product code LLL
ApplicantClearances
Inova Diagnostics, Inc.37
Hemagen Diagnostics, Inc.16
Diamedix Corp.10
Hycor Biomedical10
Zeus Scientific LLC9
Advanced Biological Products, Inc.8
Immco Diagnostics, Inc.8
IMMUNO CONCEPTS, NA, Ltd.8
Cogent Diagnotics, Ltd.7
Trinity Biotech USA6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order