LICClass II

Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae

21 CFR 866.3390 / Microbiology

LIC is the FDA product code for Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae, a class II device type, regulated under 21 CFR 866.3390. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1992-05-22, and no recalls.

Classification record

Product code: LIC
Device name: Antiserum, Coagglutination (Direct) 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: 9
Ingested recalls: 0

Clearances, product code LIC

By decision year

9 clearances under product code LIC with a decision year between 1982 and 1992, 1982 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LIC by decision year
Year	Clearances
1982	2
1985	2
1987	2
1988	1
1991	1
1992	1

Applicants with the most clearances

Product code LIC

Applicants holding the most 510(k) clearances under product code LIC
Applicant	Clearances
New Horizons Diagnostics Co.	3
Pharmacia, Inc.	2
Bainbridge Laboratories, Inc.	1
Karo Bio Diagnostics AB	1
Meridian Diagnostics, Inc.	1
Novo Nordisk Diagnostics, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

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