Home / 510(k) Clearances / K090239

510(k) K090239

PROGASTRO CD ASSAY by Prodesse, Inc. — Product Code LLH

K090239 is an FDA 510(k) premarket notification submitted by Prodesse, Inc. for the device "PROGASTRO CD ASSAY". The FDA issued a decision of Substantially Equivalent on April 16, 2009. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Prodesse, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2009
Date Received
February 2, 2009
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 Prodesse, Inc.

  • K091053 — PROPARAFLU+ASSAY (November 20, 2009)
  • K092500 — MODIFICATION TO PROFLU+ ASSAY (August 20, 2009)
  • K082688 — PRO HMPV+ ASSAY (November 7, 2008)
  • K081030 — MODIFICATION TO PROFLU+ ASSAY (May 2, 2008)
  • K073029 — PROFLU+ ASSAY (January 4, 2008)

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)
  • 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