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510(k) K782013

GONO-CELL by Abbott Laboratories — Product Code JSX

K782013 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "GONO-CELL". The FDA issued a decision of Substantially Equivalent on April 23, 1979. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
December 5, 1978
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

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  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

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)
  • K852582 — GONI-KIT (July 12, 1985)
  • K833307 — PHADEBACK G.C. POSITIVE CONTROLS (December 27, 1983)

FDA data resources