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510(k) K821362

IMPROVED GONO GEN by New Horizons Diagnostics Co. — Product Code LIC

K821362 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "IMPROVED GONO GEN". The FDA issued a decision of Substantially Equivalent on Aug 4, 1982. 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
Aug 4, 1982
Date Received
May 7, 1982
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) (Jun 27, 1995)
  • K925190 — PYLORISCREEN (Mar 23, 1993)
  • K922432 — CHOLERASCREEN (Dec 7, 1992)
  • K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST (Feb 19, 1988)
  • K871226 — SYPHILIS SEROLOGICAL REAGENTS (May 28, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K862195 — RAPID BACTERIURIA SCREEN (RBS) (Jun 30, 1986)
  • K851132 — LATEX AGGLUTINATION TEST (Jul 5, 1985)
  • K820007 — NEISSERIA GONORRHOEAE TEST (Jan 29, 1982)

Other clearances for product code LIC

  • K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION (May 22, 1992)
  • K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION (Aug 7, 1991)
  • K880076 — G-MARK (Jul 1, 1988)
  • K874078 — MERITEC(TM)-GC (Dec 9, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K851650 — PHADEBACT MONOCLONAL GC OMNI TEST (Jul 12, 1985)
  • K850351 — PHADEBACT MONOCLONAL GC TEST (Mar 13, 1985)
  • K820007 — NEISSERIA GONORRHOEAE TEST (Jan 29, 1982)

FDA data resources