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510(k) K983399

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY by Genzyme Diagnostics — Product Code MHI

K983399 is an FDA 510(k) premarket notification submitted by Genzyme Diagnostics for the device "GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Genzyme Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1999
Date Received
September 28, 1998
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 Genzyme Diagnostics

  • K043385 — OSOM HCG COMBO TEST (April 12, 2005)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K964155 — CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (November 25, 1996)
  • K964156 — CONTRAST STRIP HCG (November 25, 1996)

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)
  • K020583 — IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (September 17, 2002)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K982245 — TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE (October 6, 1998)

FDA data resources