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510(k) K913426

ALBICANS SURE by Jrga Diagnostics — Product Code JXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1992
Date Received
August 1, 1991
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

Other clearances for product code JXC

  • K960075 — CHROMAGAR CANDIDA (August 2, 1996)
  • 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)