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510(k) K132010

VIDAS C DIFFICILE GDH by Biomerieux S.A. — Product Code MCB

K132010 is an FDA 510(k) premarket notification submitted by Biomerieux S.A. for the device "VIDAS C DIFFICILE GDH". The FDA issued a decision of Substantially Equivalent on October 9, 2013. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Biomerieux S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2013
Date Received
July 1, 2013
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

  • K112048 — IMMUNOCARD C. DIFFICILE GDH (December 16, 2011)
  • 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)
  • K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (March 12, 1990)
  • K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (May 21, 1984)

FDA data resources