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510(k) K833180

GONOCHEK-II by E-Y Laboratories, Inc. — Product Code JSX

K833180 is an FDA 510(k) premarket notification submitted by E-Y Laboratories, Inc. for the device "GONOCHEK-II". The FDA issued a decision of Substantially Equivalent on November 14, 1983. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. E-Y Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
September 19, 1983
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 E-Y Laboratories, Inc.

  • K934130 — SWABZYME OXIDASE (September 14, 1994)
  • K940161 — B-LACTAMASE REAGENT TUBES (September 9, 1994)
  • K940162 — GONOCHEK II REAGENT TUBES (September 9, 1994)
  • K934125 — GONOCHEK-II, MODIFICATION (September 9, 1994)
  • K940020 — STREP-A-CHEK(TM) REAGENT STRIPS (August 26, 1994)
  • K940124 — EY-20 REAGENT TUBES (August 26, 1994)
  • K934129 — STREP-A-CHEK (August 26, 1994)
  • K844276 — E-COLI-CHEK TUBE (December 13, 1984)
  • K842600 — STREP-A-CHEK (July 11, 1984)
  • K840810 — SWABZYME-OXIDASE (April 4, 1984)

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