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510(k) K081920

BD GENEOHM CDIFF ASSAY by Bd Diagnostics (Geneohm Sciences, Inc.) — Product Code LLH

K081920 is an FDA 510(k) premarket notification submitted by Bd Diagnostics (Geneohm Sciences, Inc.) for the device "BD GENEOHM CDIFF ASSAY". The FDA issued a decision of Substantially Equivalent on December 19, 2008. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Bd Diagnostics (Geneohm Sciences, Inc.) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
July 3, 2008
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 Bd Diagnostics (Geneohm Sciences, Inc.)

  • K093346 — BD GENEOHM MRSA ACP ASSAY (December 15, 2009)

Other clearances for product code LLH

  • K193490 — SensiTox C. difficile Toxin Test (July 8, 2021)
  • K102242 — OSOM C. DIFFICILE TOXIN A/B TEST (December 21, 2010)
  • K091109 — XPERT C. DIFFICILE (July 9, 2009)
  • K090239 — PROGASTRO CD ASSAY (April 16, 2009)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • 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