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510(k) K883560

CDT CYTOTOXI TEST by Advanced Clinical Diagnostics — Product Code LLH

K883560 is an FDA 510(k) premarket notification submitted by Advanced Clinical Diagnostics for the device "CDT CYTOTOXI TEST". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Advanced Clinical Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1988
Date Received
August 19, 1988
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 Advanced Clinical Diagnostics

  • K936171 — TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY (February 3, 1994)
  • K936169 — RHESUS MONKEY KIDNEY CELLS (February 3, 1994)
  • K936172 — RHESUS MONKEY KIDNEY CELLS (LLC-MK2) (February 3, 1994)
  • K934973 — HELA-229/HELA CELLS (January 28, 1994)
  • K934934 — RABBIT KIDNEY CELLS - R.K.C. (January 28, 1994)
  • K935766 — PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (January 24, 1994)
  • K934241 — MCCOY CULTURE CELLS-MCCOY (January 3, 1994)
  • K935338 — LUNG CACINOMA, HUMAN CELLS (January 3, 1994)
  • K934246 — LUNG DIPLOID HUMAN CELLS-WI-38 (January 3, 1994)
  • K935339 — HELA HELA EPITHELOID CARCINOMA (January 3, 1994)

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