Product code LIC— Microbiology
G-MARK
- Classification name
- Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code LIC
FDA has cleared devices under product code LIC between 1982 and 1992, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1992
- 1991
- 1988
- 1987
- 1985
- 1982
Top applicants under product code LIC
Recent clearances under product code LIC
- K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION
- K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION
- K880076 — G-MARK
- K874078 — MERITEC(TM)-GC
- K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
- K851650 — PHADEBACT MONOCLONAL GC OMNI TEST
- K850351 — PHADEBACT MONOCLONAL GC TEST
- K821362 — IMPROVED GONO GEN
- K820007 — NEISSERIA GONORRHOEAE TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.