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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 Oct 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 271 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 9, 2013
Date Received
Jul 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
510(k) Exempt

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  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (Mar 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (Aug 21, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (Apr 30, 2025)
  • K234012 — VITEK COMPACT PRO (Mar 14, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (Jun 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (Jun 7, 2024)
  • K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)

Other clearances for product code MCB

  • K112048 — IMMUNOCARD C. DIFFICILE GDH (Dec 16, 2011)
  • K110620 — PREMIER C. DIFFICILE GDH (May 3, 2011)
  • K053572 — C. DIFF QUIK CHEK (Apr 26, 2006)
  • K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (Mar 20, 1998)
  • K955067 — CLEARVIEW C. DIFF A (Sep 13, 1996)
  • K924062 — MERITEC C. DIFFICILE CONTROLS (Oct 19, 1992)
  • K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (Mar 12, 1991)
  • K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (Mar 12, 1990)
  • K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (May 21, 1984)

FDA data resources

Source: FDA 510(k) database entry for K132010. Report a data issue: hello@regdatalab.com.