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510(k) K871105

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE by New Horizons Diagnostics Co. — Product Code LIC

K871105 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE". The FDA issued a decision of Substantially Equivalent on May 13, 1987. The device falls under product code LIC (Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1987
Date Received
March 19, 1987
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 New Horizons Diagnostics Co.

  • K932622 — CHOLERA SMART(TM) (June 27, 1995)
  • K925190 — PYLORISCREEN (March 23, 1993)
  • K922432 — CHOLERASCREEN (December 7, 1992)
  • K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST (February 19, 1988)
  • K871226 — SYPHILIS SEROLOGICAL REAGENTS (May 28, 1987)
  • K862195 — RAPID BACTERIURIA SCREEN (RBS) (June 30, 1986)
  • K851132 — LATEX AGGLUTINATION TEST (July 5, 1985)
  • K821362 — IMPROVED GONO GEN (August 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)

Other clearances for product code LIC

  • K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION (May 22, 1992)
  • K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION (August 7, 1991)
  • K880076 — G-MARK (July 1, 1988)
  • K874078 — MERITEC(TM)-GC (December 9, 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