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510(k) K911337

PROSPEC T/GIARDIA RAPID ASSAY by Alexon, Inc. — Product Code MHI

K911337 is an FDA 510(k) premarket notification submitted by Alexon, Inc. for the device "PROSPEC T/GIARDIA RAPID ASSAY". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Alexon, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
March 26, 1991
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)
  • K922010 — PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION (June 19, 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)

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