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510(k) K991829

CDTOX A OIA by Biostar, Inc. — Product Code LLH

K991829 is an FDA 510(k) premarket notification submitted by Biostar, Inc. for the device "CDTOX A OIA". The FDA issued a decision of Substantially Equivalent on November 2, 1999. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Biostar, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1999
Date Received
May 28, 1999
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 Biostar, Inc.

  • K991828 — STREP B OIA (August 19, 1999)
  • K981651 — AB FLU OIA (November 25, 1998)
  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)
  • K936112 — STREP B OIA (July 6, 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