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

Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

21 CFR 866.5420 / Immunology
FDA source (opens on fda.gov)

LKL is the FDA product code for Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5420. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKL
Device name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5420
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code LKL

By decision year
11 clearances under product code LKL with a decision year between 1983 and 1999, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LKL by decision year
YearClearances
19831
19841
19862
19871
19881
19901
19921
19972
19991

Applicants with the most clearances

Product code LKL
Applicants holding the most 510(k) clearances under product code LKL
ApplicantClearances
Scientific Sales Intl., Inc.2
Beckman Instruments, Inc.1
Crestat Diagnostics, Inc.1
Kamiya Biomedical Company, LLC1
Kent Laboratories, Inc.1
Reagents Applications, Inc.1
Tago, Inc.1
Technicon Instruments Corp.1
The Binding Site1
Unipath, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order