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510(k) K921075

PHADEBACT MONOCLONAL GC TEST, MODIFICATION by Karo Bio Diagnostics AB — Product Code LIC

K921075 is an FDA 510(k) premarket notification submitted by Karo Bio Diagnostics AB for the device "PHADEBACT MONOCLONAL GC TEST, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 22, 1992. The device falls under product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1992
Date Received
February 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

Other clearances for product code LIC

  • K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION (August 7, 1991)
  • K880076 — G-MARK (July 1, 1988)
  • K874078 — MERITEC(TM)-GC (December 9, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K851650 — PHADEBACT MONOCLONAL GC OMNI TEST (July 12, 1985)
  • K850351 — PHADEBACT MONOCLONAL GC TEST (March 13, 1985)
  • K821362 — IMPROVED GONO GEN (August 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)

FDA data resources