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

N-Acetylprocainamide Control Materials

21 CFR 862.3280 / Clinical Toxicology
FDA source (opens on fda.gov)

LAZ is the FDA product code for N-Acetylprocainamide Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LAZ
Device name
N-Acetylprocainamide Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code LAZ

By decision year
4 clearances under product code LAZ with a decision year between 1981 and 2021, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LAZ by decision year
YearClearances
19811
19821
19851
20211

Applicants with the most clearances

Product code LAZ
Applicants holding the most 510(k) clearances under product code LAZ
ApplicantClearances
Syva Co.2
Changzhou Universal Medical Equipment Co., Ltd.1
Vygon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LAZ.