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510(k) K053572

C. DIFF QUIK CHEK by Techlab, Inc. — Product Code MCB

K053572 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "C. DIFF QUIK CHEK". The FDA issued a decision of Substantially Equivalent on April 26, 2006. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Techlab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2006
Date Received
December 22, 2005
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 Techlab, Inc.

  • K191442 — Campylobacter Chek (June 20, 2019)
  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 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)
  • K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (March 20, 1998)
  • 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