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510(k) K953284

TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM by Trend Scientific, Inc. — Product Code MHI

K953284 is an FDA 510(k) premarket notification submitted by Trend Scientific, Inc. for the device "TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 1995. The device falls under product code MHI (Giardia Spp.), a Class II device regulated under 21 CFR 866.3220. Trend Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1995
Date Received
July 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 Trend Scientific, Inc.

  • K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM (August 8, 1996)
  • K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS (July 11, 1996)
  • K952467 — TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (November 20, 1995)
  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)
  • K830769 — FEKAL CON-TRATE SYSTEM (April 5, 1983)

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