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

Procainamide Control Materials

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

LBA is the FDA product code for Procainamide Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LBA
Device name
Procainamide 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
1
Ingested recalls
0

Clearances, product code LBA

By decision year
1 clearance under product code LBA with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LBA by decision year
YearClearances
19831

Applicants with the most clearances

Product code LBA
Applicants holding the most 510(k) clearances under product code LBA
ApplicantClearances
Sonicaid, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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