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510(k) K884720

GERM TUBE SOLUTION by Remel Co. — Product Code JXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1989
Date Received
November 10, 1988
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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  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

Other clearances for product code JXC

  • K960075 — CHROMAGAR CANDIDA (August 2, 1996)
  • K913426 — ALBICANS SURE (April 22, 1992)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882371 — SOC SLIDE CULTURE SYSTEM (July 18, 1988)
  • K832406 — QUANTUM II YEAST IDENT. SYSTEM (September 26, 1983)