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510(k) K964424

ROTAVIRUS EIA by Trinity Biotech, Inc. — Product Code LIQ

K964424 is an FDA 510(k) premarket notification submitted by Trinity Biotech, Inc. for the device "ROTAVIRUS EIA". The FDA issued a decision of Substantially Equivalent on August 8, 1997. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Trinity Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1997
Date Received
November 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

Other clearances by Trinity Biotech, Inc.

  • K172254 — Lyme B. burgdorferi (IgM) MarStripe Test (October 23, 2017)
  • K163095 — Lyme B. burgdorferi (IgG) MarStripe Test (February 1, 2017)
  • K120001 — UNIGOLD GIARDIA (March 1, 2013)
  • K121565 — UNI-GOLD CRYPTOSPORIDIUM (February 8, 2013)
  • K083896 — DESTINY MAX COAGULATION ANALYZER (July 2, 2009)
  • K033059 — HERPES GROUP IGG (November 26, 2003)
  • K014233 — CAPTIAM SYPHILIS-G ASSAY (January 24, 2002)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM (November 29, 2000)
  • K991697 — UNI-GOLD H. PYLORI (December 21, 1999)

Other clearances for product code LIQ

  • K990842 — SAS ROTA TEST (August 9, 1999)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT (February 14, 1996)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K933587 — IMMUNOCARD ROTAVIRUS (February 3, 1994)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)
  • K915137 — KALLESTAD ROTAVIRUS MICROPLATE (March 4, 1992)
  • K912666 — DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (February 14, 1992)

FDA data resources