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 Mar 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 45 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 20, 1998
Date Received
Dec 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
510(k) Exempt

Other clearances by Biosite Incorporated

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  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (Apr 19, 2010)
  • K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (Nov 13, 2009)
  • K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (Jun 6, 2008)
  • K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (Dec 7, 2007)
  • K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (Mar 1, 2007)
  • K062530 — TRIAGE PROTEIN C TEST (Jan 29, 2007)
  • K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (Jul 10, 2006)
  • K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400 (Jun 22, 2006)
  • K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (Jan 23, 2006)

Other clearances for product code MCB

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

FDA data resources

Source: FDA 510(k) database entry for K974881. Report a data issue: hello@regdatalab.com.