Home / 510(k) Clearances / K974881

510(k) K974881

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A by Biosite Incorporated — Product Code MCB

K974881 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A". The FDA issued a decision of Substantially Equivalent on March 20, 1998. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Biosite Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1998
Date Received
December 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, C. Difficile
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Biosite Incorporated

  • K092987 — INRATIO/INRATIO2 TEST STRIPS (June 11, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)
  • K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (November 13, 2009)
  • K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (June 6, 2008)
  • K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (December 7, 2007)
  • K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (March 1, 2007)
  • K062530 — TRIAGE PROTEIN C TEST (January 29, 2007)
  • K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (July 10, 2006)
  • K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400 (June 22, 2006)
  • K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (January 23, 2006)

Other clearances for product code MCB

  • K132010 — VIDAS C DIFFICILE GDH (October 9, 2013)
  • K112048 — IMMUNOCARD C. DIFFICILE GDH (December 16, 2011)
  • K110620 — PREMIER C. DIFFICILE GDH (May 3, 2011)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)
  • K955067 — CLEARVIEW C. DIFF A (September 13, 1996)
  • K924062 — MERITEC C. DIFFICILE CONTROLS (October 19, 1992)
  • K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (March 12, 1991)
  • K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (March 12, 1990)
  • K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (May 21, 1984)

FDA data resources