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510(k) K960075

CHROMAGAR CANDIDA by Hardy Diagnostics — Product Code JXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Yeast
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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Other clearances for product code JXC

  • K913426 — ALBICANS SURE (April 22, 1992)
  • K884720 — GERM TUBE SOLUTION (June 2, 1989)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882371 — SOC SLIDE CULTURE SYSTEM (July 18, 1988)
  • K832406 — QUANTUM II YEAST IDENT. SYSTEM (September 26, 1983)