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510(k) K033059

HERPES GROUP IGG by Trinity Biotech, Inc. — Product Code LGC

K033059 is an FDA 510(k) premarket notification submitted by Trinity Biotech, Inc. for the device "HERPES GROUP IGG". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific), a Class II device regulated under 21 CFR 866.3305. Trinity Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Device Class
Class II
Regulation Number
866.3305
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)
  • 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)
  • K982373 — UNI-GOLD STREP A TEST KIT (February 11, 1999)

Other clearances for product code LGC

  • K010878 — MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (April 18, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)
  • K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (April 14, 2000)
  • K992166 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYM (September 3, 1999)
  • K983886 — POCKIT HSV 2 RAPID TEST (August 19, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983656 — HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (March 18, 1999)
  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)
  • K963645 — HERPES GROUP IGG ELISA TEST SYSTEM (February 4, 1997)

FDA data resources