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510(k) K103673

GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK by Techlab Inc., Corporate Research Center — Product Code MHI

K103673 is an FDA 510(k) premarket notification submitted by Techlab Inc., Corporate Research Center for the device "GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK". The FDA issued a decision of Substantially Equivalent on August 18, 2011. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Techlab Inc., Corporate Research Center has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2011
Date Received
December 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Giardia Spp.
Device Class
Class II
Regulation Number
866.3220
Review Panel
MI
Submission Type

Other clearances by Techlab Inc., Corporate Research Center

  • K121411 — SHIGA TOXIN CHEK (October 2, 2012)
  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K071712 — LEUKO EZ VUE (December 4, 2007)
  • K071711 — ASCA-CHEK (November 7, 2007)

Other clearances for product code MHI

  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (January 14, 2009)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K033274 — GIARDIA II (November 4, 2003)
  • K024113 — IVD CRYPTO/GIARDIA DFA (March 5, 2003)
  • K020583 — IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (September 17, 2002)
  • K983399 — GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (January 11, 1999)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K982245 — TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE (October 6, 1998)

FDA data resources