Home / 510(k) Clearances / K852582

510(k) K852582

GONI-KIT by Culture Kits, Inc. — Product Code JSX

K852582 is an FDA 510(k) premarket notification submitted by Culture Kits, Inc. for the device "GONI-KIT". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Culture Kits, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1985
Date Received
June 18, 1985
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 Culture Kits, Inc.

  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)
  • K854672 — CANDI-KIT TM (July 11, 1986)
  • K853488 — STAPH KIT (August 28, 1985)
  • K851225 — URINE DUO (August 13, 1985)
  • K852480 — DERM-KIT (July 9, 1985)
  • K851518 — MUELLER HINTON SENSITIVITY PLATE (April 29, 1985)
  • K850765 — STREP-KIT (April 24, 1985)
  • K850998 — URI-KIT (April 1, 1985)

Other clearances for product code JSX

  • K960759 — GONOPOX TEST KIT (September 18, 1996)
  • 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)
  • K833307 — PHADEBACK G.C. POSITIVE CONTROLS (December 27, 1983)
  • K833180 — GONOCHEK-II (November 14, 1983)

FDA data resources