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

Enzyme Immunoassay, Valproic Acid

21 CFR 862.3645 / Clinical Toxicology
FDA source (opens on fda.gov)

LEG is the FDA product code for Enzyme Immunoassay, Valproic Acid, a class II device type, regulated under 21 CFR 862.3645. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LEG
Device name
Enzyme Immunoassay, Valproic Acid
Regulation
21 CFR 862.3645
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
35
Ingested recalls
7

Clearances, product code LEG

By decision year
35 clearances under product code LEG with a decision year between 1980 and 2009, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LEG by decision year
YearClearances
19801
19811
19821
19832
19861
19892
19901
19911
19922
19932
19943
19951
19963
19972
19981
20002
20011
20021
20033
20041
20051
20061
20091

Applicants with the most clearances

Product code LEG
Applicants holding the most 510(k) clearances under product code LEG
ApplicantClearances
Siemens Healthcare Diagnostics Inc.4
Abbott Medical3
Roche Diagnostic Systems, Inc.3
Syva Co.3
Beckman Instruments, Inc.2
Roche Diagnostics GmbH2
Seradyn, Inc.2
Sigma Diagnostics, Inc.2
Bayer Corp.1
Medrad, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order