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

Enzyme Immunoassay, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology
FDA source (opens on fda.gov)

DLZ is the FDA product code for Enzyme Immunoassay, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
DLZ
Device name
Enzyme Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
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
9

Clearances, product code DLZ

By decision year
35 clearances under product code DLZ with a decision year between 1977 and 2021, 1986 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DLZ by decision year
YearClearances
19771
19801
19812
19832
19843
19852
19864
19872
19881
19901
19912
19943
19952
19991
20002
20012
20071
20081
20131
20211

Applicants with the most clearances

Product code DLZ
Applicants holding the most 510(k) clearances under product code DLZ
ApplicantClearances
Abbott Medical3
Syva Co.3
Em Diagnostic Systems, Inc.2
Instrumentation Laboratory Co.2
Ortho-Clinical Diagnostics, Inc.2
Syva Co.2
Syva Co.2
Allied Instrumentation Laboratory1
Baxter Diagnostics, Inc.1
Beckman Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order