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510(k) K913456

VISI-NEISSERIA by Kev Connecticut Diagnostics, Inc. — Product Code JSX

K913456 is an FDA 510(k) premarket notification submitted by Kev Connecticut Diagnostics, Inc. for the device "VISI-NEISSERIA". The FDA issued a decision of Substantially Equivalent on October 11, 1991. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Kev Connecticut Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1991
Date Received
August 5, 1991
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 by Kev Connecticut Diagnostics, Inc.

  • K910537 — VISI-STREP (April 12, 1991)

Other clearances for product code JSX

  • K960759 — GONOPOX TEST KIT (September 18, 1996)
  • K923566 — NIZYME TEST KIT (November 2, 1992)
  • 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