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

Enzyme Immunoassay, Procainamide

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

LAR is the FDA product code for Enzyme Immunoassay, Procainamide, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LAR
Device name
Enzyme Immunoassay, Procainamide
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
25
Ingested recalls
0

Clearances, product code LAR

By decision year
25 clearances under product code LAR with a decision year between 1978 and 2006, 1996 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LAR by decision year
YearClearances
19781
19791
19812
19821
19833
19841
19852
19861
19871
19921
19942
19951
19964
19971
20011
20031
20061

Applicants with the most clearances

Product code LAR
Applicants holding the most 510(k) clearances under product code LAR
ApplicantClearances
Syva Co.6
Abbott Medical2
Boehringer Mannheim Corp.2
Roche Diagnostic Systems, Inc.2
American Dade1
Bayer Corp.1
Behring Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
Diagnostic Reagents, Inc.1
E.I. Dupont de Nemours & Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code