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510(k) K120001

UNIGOLD GIARDIA by Trinity Biotech — Product Code MHI

K120001 is an FDA 510(k) premarket notification submitted by Trinity Biotech for the device "UNIGOLD GIARDIA". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Trinity Biotech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
January 3, 2012
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 Trinity Biotech

  • K172254 — Lyme B. burgdorferi (IgM) MarStripe Test (October 23, 2017)
  • K163095 — Lyme B. burgdorferi (IgG) MarStripe Test (February 1, 2017)
  • K121565 — UNI-GOLD CRYPTOSPORIDIUM (February 8, 2013)
  • K083896 — DESTINY MAX COAGULATION ANALYZER (July 2, 2009)
  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K014233 — CAPTIAM SYPHILIS-G ASSAY (January 24, 2002)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM (November 29, 2000)
  • K991697 — UNI-GOLD H. PYLORI (December 21, 1999)
  • K982373 — UNI-GOLD STREP A TEST KIT (February 11, 1999)

Other clearances for product code MHI

  • K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (August 18, 2011)
  • 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