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510(k) K940162

GONOCHEK II REAGENT TUBES by E-Y Laboratories, Inc. — Product Code JTO

K940162 is an FDA 510(k) premarket notification submitted by E-Y Laboratories, Inc. for the device "GONOCHEK II REAGENT TUBES". The FDA issued a decision of Substantially Equivalent on September 9, 1994. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), 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
September 9, 1994
Date Received
January 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
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)
  • K934125 — GONOCHEK-II, MODIFICATION (September 9, 1994)
  • K940161 — B-LACTAMASE REAGENT TUBES (September 9, 1994)
  • K940124 — EY-20 REAGENT TUBES (August 26, 1994)
  • K940020 — STREP-A-CHEK(TM) REAGENT STRIPS (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)
  • K840884 — STREP-A-CHEK TUBE (March 23, 1984)

Other clearances for product code JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources