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

Enzyme Immunoassay, Quinidine

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

LBZ is the FDA product code for Enzyme Immunoassay, Quinidine, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LBZ
Device name
Enzyme Immunoassay, Quinidine
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
27
Ingested recalls
2

Clearances, product code LBZ

By decision year
27 clearances under product code LBZ with a decision year between 1981 and 2005, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LBZ by decision year
YearClearances
19812
19822
19834
19843
19851
19862
19872
19891
19901
19911
19921
19941
19963
20011
20041
20051

Applicants with the most clearances

Product code LBZ
Applicants holding the most 510(k) clearances under product code LBZ
ApplicantClearances
Syva Co.4
Abbott Medical3
Innotron of Oregon, Inc.2
Roche Diagnostic Systems, Inc.2
Syva Co.2
American Dade1
American Diagnostic Corp.1
Bayer Corp.1
Beckman Instruments, Inc.1
Clinical Data, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code