FDA product code LIC: Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
LIC is the FDA product code for antiserum, coagglutination (direct) neisseria gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under LIC, from 6 different applicants. The average 510(k) review took 83 days (median 81).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LIC clearance
Top LIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| New Horizons Diagnostics Co. | 3 | 1987-05-13 |
| Pharmacia, Inc. | 2 | 1985-07-12 |
| Karo Bio Diagnostics AB | 1 | 1992-05-22 |
| Novo Nordisk Diagnostics, Ltd. | 1 | 1991-08-07 |
| Bainbridge Laboratories, Inc. | 1 | 1988-07-01 |
1 more applicants have LIC clearances. See the full list in Caduvo.
Most recent LIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921075 | Karo Bio Diagnostics AB | PHADEBACT MONOCLONAL GC TEST, MODIFICATION | 1992-05-22 | 84 |
| K911430 | Novo Nordisk Diagnostics, Ltd. | IDEIA(TM) CHLAMYDIA, MODIFICATION | 1991-08-07 | 132 |
| K880076 | Bainbridge Laboratories, Inc. | G-MARK | 1988-07-01 | 172 |
| K874078 | Meridian Diagnostics, Inc. | MERITEC(TM)-GC | 1987-12-09 | 64 |
| K871105 | New Horizons Diagnostics Co. | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | 1987-05-13 | 55 |
Recalls for LIC devices
openFDA lists no recalls for product code LIC.
Frequently asked questions
What is FDA product code LIC?
LIC is the FDA product code for antiserum, coagglutination (direct) neisseria gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is LIC?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIC?
Across 9 cleared submissions the average was 83 days from receipt to decision (median 81).
Which companies have the most LIC clearances?
New Horizons Diagnostics Co. (3); Pharmacia, Inc. (2); Karo Bio Diagnostics AB (1); Novo Nordisk Diagnostics, Ltd. (1); Bainbridge Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LIC
- Run a recall and safety report across every LIC manufacturer
- Watch product code LIC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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