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510(k) K964864

PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY by Alexon Biomedical, Inc. — Product Code LLH

K964864 is an FDA 510(k) premarket notification submitted by Alexon Biomedical, Inc. for the device "PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on February 4, 1997. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Alexon Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1997
Date Received
December 4, 1996
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 Alexon Biomedical, Inc.

  • K955157 — PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (February 9, 1996)
  • K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (November 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K874849 — PROSPECT/GIARDIA (January 5, 1988)

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