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510(k) K020583

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 by Ivd Research, Inc. — Product Code MHI

K020583 is an FDA 510(k) premarket notification submitted by Ivd Research, Inc. for the device "IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96". The FDA issued a decision of Substantially Equivalent on September 17, 2002. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Ivd Research, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2002
Date Received
February 21, 2002
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 Ivd Research, Inc.

  • K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (January 14, 2009)
  • K032897 — C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIF (May 27, 2004)
  • K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (July 10, 2003)
  • K024113 — IVD CRYPTO/GIARDIA DFA (March 5, 2003)

Other clearances for product code MHI

  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • 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)
  • 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