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

Anti-Sm Antibody, Antigen And Control

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

LKP is the FDA product code for Anti-Sm Antibody, Antigen And Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LKP
Device name
Anti-Sm 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
28
Ingested recalls
1

Clearances, product code LKP

By decision year
28 clearances under product code LKP with a decision year between 1984 and 2021, 1998 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LKP by decision year
YearClearances
19841
19871
19882
19891
19902
19912
19931
19941
19962
19984
19991
20002
20021
20031
20041
20051
20131
20141
20181
20211

Applicants with the most clearances

Product code LKP
Applicants holding the most 510(k) clearances under product code LKP
ApplicantClearances
Phadia AB3
Bio-Rad2
General Biometrics, Inc.2
Lipogen, Inc.2
Quest Intl., Inc.2
Shield Diagnostics, Ltd.2
American Bionetics, Inc.1
Cogent Diagnotics, Ltd.1
Diagnostic Chemicals, Ltd. (USA)1
Elias U.S.A., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code