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510(k) K922010

PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION by Alexon, Inc. — Product Code MHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1992
Date Received
April 30, 1992
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, Inc.

  • K934493 — PROSPECT MICROPLATE ASSAY (September 20, 1994)
  • K942098 — PROSPECT GIARDIA (September 9, 1994)
  • K931147 — PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION (May 13, 1993)
  • K930451 — PROSPEC T GIARDIA MICROTITER ASSAY (April 21, 1993)
  • K922675 — PROSPECT GIARDIA CONTROLS (September 11, 1992)
  • K920817 — MODIFICATION PROSPECT GIARDIA RAPID ASSAY (April 22, 1992)
  • K912242 — PROSPECT(TM/CRYPTOSPORIDIUM (March 23, 1992)
  • K915093 — PROSPECT(TM) GIARDIA RAPID ASSAY (January 30, 1992)
  • K911337 — PROSPEC T/GIARDIA RAPID ASSAY (September 27, 1991)

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)