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510(k) K193490

SensiTox C. difficile Toxin Test by First Light Diagnostics, Inc. — Product Code LLH

K193490 is an FDA 510(k) premarket notification submitted by First Light Diagnostics, Inc. for the device "SensiTox C. difficile Toxin Test". The FDA issued a decision of Substantially Equivalent on July 8, 2021. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. First Light Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
December 17, 2019
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 First Light Diagnostics, Inc.

  • K232545 — The SensiTox B. anthracis Toxin Test (November 20, 2023)

Other clearances for product code LLH

  • 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)
  • K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050 (August 20, 2004)

FDA data resources