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

Kit, Igg, Platelet Associated

21 CFR 864.5425 / Hematology
FDA source (opens on fda.gov)

LLG is the FDA product code for Kit, Igg, Platelet Associated, a class II device type, regulated under 21 CFR 864.5425. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LLG
Device name
Kit, Igg, Platelet Associated
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
1

Clearances, product code LLG

By decision year
2 clearances under product code LLG with a decision year between 1984 and 1984, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LLG by decision year
YearClearances
19842

Applicants with the most clearances

Product code LLG
Applicants holding the most 510(k) clearances under product code LLG
ApplicantClearances
Applied Polytechnology, Inc.1
General Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code

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