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510(k) K102242

OSOM C. DIFFICILE TOXIN A/B TEST by Genzyme Corporation — Product Code LLH

K102242 is an FDA 510(k) premarket notification submitted by Genzyme Corporation for the device "OSOM C. DIFFICILE TOXIN A/B TEST". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Genzyme Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
August 9, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Clostridium Difficile Toxin
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Genzyme Corporation

  • K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190 (September 25, 2009)
  • K080662 — GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR (May 15, 2008)
  • K063739 — SEPRAMESH, MODEL 5959-1214 (January 17, 2007)
  • K053066 — SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH (December 19, 2005)
  • K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT (July 11, 2005)

Other clearances for product code LLH

  • K193490 — SensiTox C. difficile Toxin Test (July 8, 2021)
  • K091109 — XPERT C. DIFFICILE (July 9, 2009)
  • K090239 — PROGASTRO CD ASSAY (April 16, 2009)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K081920 — BD GENEOHM CDIFF ASSAY (December 19, 2008)
  • K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (June 11, 2008)
  • K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (December 21, 2007)
  • K050891 — TOX A/B QUICK CHEK (July 25, 2005)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050 (August 20, 2004)

FDA data resources