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510(k) K960759

GONOPOX TEST KIT by Medtex Laboratories, Inc. — Product Code JSX

K960759 is an FDA 510(k) premarket notification submitted by Medtex Laboratories, Inc. for the device "GONOPOX TEST KIT". The FDA issued a decision of Substantially Equivalent on September 18, 1996. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1996
Date Received
February 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Neisseria Gonorrhoeae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances for product code JSX

  • K923566 — NIZYME TEST KIT (November 2, 1992)
  • K913456 — VISI-NEISSERIA (October 11, 1991)
  • K880511 — XACT NEISSERIA (August 25, 1988)
  • K881501 — MODIFIED IDS RAPID NH SYSTEM (May 18, 1988)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K853544 — QUAD FERM + (September 5, 1985)
  • K852998 — NEISSERIA - KWIK PLUS (July 23, 1985)
  • K852582 — GONI-KIT (July 12, 1985)
  • K833307 — PHADEBACK G.C. POSITIVE CONTROLS (December 27, 1983)
  • K833180 — GONOCHEK-II (November 14, 1983)

FDA data resources