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510(k) K895915

MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM by Meridian Diagnostics, Inc. — Product Code MCB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1990
Date Received
October 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, C. Difficile
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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Other clearances for product code MCB

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  • K110620 — PREMIER C. DIFFICILE GDH (May 3, 2011)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)
  • K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (March 20, 1998)
  • K955067 — CLEARVIEW C. DIFF A (September 13, 1996)
  • K924062 — MERITEC C. DIFFICILE CONTROLS (October 19, 1992)
  • K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (March 12, 1991)
  • K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (May 21, 1984)