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

Enzyme Immunoassay, Lidocaine

21 CFR 862.3555 / Clinical Toxicology
FDA source (opens on fda.gov)

KLR is the FDA product code for Enzyme Immunoassay, Lidocaine, a class II device type, regulated under 21 CFR 862.3555. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KLR
Device name
Enzyme Immunoassay, Lidocaine
Regulation
21 CFR 862.3555
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
1

Clearances, product code KLR

By decision year
17 clearances under product code KLR with a decision year between 1980 and 2009, 1983 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code KLR by decision year
YearClearances
19802
19821
19837
19841
19851
19881
19971
20042
20091

Applicants with the most clearances

Product code KLR
Applicants holding the most 510(k) clearances under product code KLR
ApplicantClearances
Syva Co.5
E.I. Dupont de Nemours & Co., Inc.2
Abbott Medical1
American Dade1
American Diagnostic Corp.1
Siemens Healthcare Diagnostics Inc.1
Diagnostic Reagents, Inc.1
Diagnostic Systems1
Roche Diagnostic Systems, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code