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510(k) K934125

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
August 12, 1993
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

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  • 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)

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