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510(k) K911430

IDEIA(TM) CHLAMYDIA, MODIFICATION by Novo Nordisk Diagnostics, Ltd. — Product Code LIC

K911430 is an FDA 510(k) premarket notification submitted by Novo Nordisk Diagnostics, Ltd. for the device "IDEIA(TM) CHLAMYDIA, MODIFICATION". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Novo Nordisk Diagnostics, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
March 28, 1991
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 by Novo Nordisk Diagnostics, Ltd.

  • K901972 — ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA (September 5, 1990)

Other clearances for product code LIC

  • K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION (May 22, 1992)
  • 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