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

Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae

21 CFR 866.3390 / Microbiology
FDA source (opens on fda.gov)

LIR is the FDA product code for Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae, a class II device type, regulated under 21 CFR 866.3390. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LIR
Device name
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Regulation
21 CFR 866.3390
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
3
Ingested recalls
0

Clearances, product code LIR

By decision year
3 clearances under product code LIR with a decision year between 1988 and 2003, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LIR by decision year
YearClearances
19882
20031

Applicants with the most clearances

Product code LIR
Applicants holding the most 510(k) clearances under product code LIR
ApplicantClearances
Abbott Medical1
Hygeia Sciences1
Thermo Biostar, 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 LIR.