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510(k) K934493

PROSPECT MICROPLATE ASSAY by Alexon, Inc. — Product Code LLH

K934493 is an FDA 510(k) premarket notification submitted by Alexon, Inc. for the device "PROSPECT MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Alexon, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
September 15, 1993
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, Inc.

  • K942098 — PROSPECT GIARDIA (September 9, 1994)
  • K931147 — PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION (May 13, 1993)
  • K930451 — PROSPEC T GIARDIA MICROTITER ASSAY (April 21, 1993)
  • K922675 — PROSPECT GIARDIA CONTROLS (September 11, 1992)
  • K922010 — PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION (June 19, 1992)
  • K920817 — MODIFICATION PROSPECT GIARDIA RAPID ASSAY (April 22, 1992)
  • K912242 — PROSPECT(TM/CRYPTOSPORIDIUM (March 23, 1992)
  • K915093 — PROSPECT(TM) GIARDIA RAPID ASSAY (January 30, 1992)
  • K911337 — PROSPEC T/GIARDIA RAPID ASSAY (September 27, 1991)

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