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510(k) K033479

PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY by Remel, Inc. — Product Code LLH

K033479 is an FDA 510(k) premarket notification submitted by Remel, Inc. for the device "PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on February 26, 2004. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Remel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2004
Date Received
November 3, 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 Remel, Inc.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (November 26, 2007)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)

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