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510(k) K032897

C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 by Ivd Research, Inc. — Product Code LLH

K032897 is an FDA 510(k) premarket notification submitted by Ivd Research, Inc. for the device "C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96". The FDA issued a decision of Substantially Equivalent on May 27, 2004. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Ivd Research, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2004
Date Received
September 17, 2003
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 Ivd Research, Inc.

  • K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (January 14, 2009)
  • K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (July 10, 2003)
  • K024113 — IVD CRYPTO/GIARDIA DFA (March 5, 2003)
  • K020583 — IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (September 17, 2002)

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)
  • 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)

FDA data resources