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

Enzyme Immunoassay, N-Acetylprocainamide

21 CFR 862.3320 / Clinical Toxicology
FDA source (opens on fda.gov)

LAN is the FDA product code for Enzyme Immunoassay, N-Acetylprocainamide, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LAN
Device name
Enzyme Immunoassay, N-Acetylprocainamide
Regulation
21 CFR 862.3320
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
21
Ingested recalls
1

Clearances, product code LAN

By decision year
21 clearances under product code LAN with a decision year between 1978 and 2006, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LAN by decision year
YearClearances
19781
19821
19834
19853
19861
19872
19891
19921
19931
19961
19971
19981
20011
20031
20061

Applicants with the most clearances

Product code LAN
Applicants holding the most 510(k) clearances under product code LAN
ApplicantClearances
Syva Co.3
Abbott Medical2
American Dade2
Roche Diagnostic Systems, Inc.2
Bayer Corp.1
Siemens Healthcare Diagnostics Inc.1
Diagnostic Reagents, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Em Diagnostic Systems, Inc.1
Miles Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code