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510(k) K955157

PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY by Alexon Biomedical, Inc. — Product Code MHI

K955157 is an FDA 510(k) premarket notification submitted by Alexon Biomedical, Inc. for the device "PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Alexon Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
November 13, 1995
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 Alexon Biomedical, Inc.

  • K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (February 4, 1997)
  • K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (November 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K874849 — PROSPECT/GIARDIA (January 5, 1988)

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)
  • K983399 — GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (January 11, 1999)
  • K982711 — PREMIER GIARDIA (November 25, 1998)

FDA data resources