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

Direct Agglutination Test, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

LLA is the FDA product code for Direct Agglutination Test, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LLA
Device name
Direct Agglutination Test, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code LLA

By decision year
4 clearances under product code LLA with a decision year between 1983 and 1993, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LLA by decision year
YearClearances
19831
19851
19891
19931

Applicants with the most clearances

Product code LLA
Applicants holding the most 510(k) clearances under product code LLA
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2
Ampcor, Inc.1
Biokit USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code