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510(k) K033079

CHLAMYDIA IGG ELISA TEST SYSTEM by Trinity Biotech USA — Product Code LJC

K033079 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "CHLAMYDIA IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Trinity Biotech USA 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, (Chlamydiae Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Trinity Biotech USA

  • K140455 — CAPTIA MEASLES IGM (May 22, 2014)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033067 — PYLORI IGG (November 26, 2003)
  • K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033064 — MYCOPLASMA IGG (November 26, 2003)
  • K993839 — ENA PROFILE ELISA TEST SYSTEM (January 12, 2000)
  • K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT (November 26, 1999)

Other clearances for product code LJC

  • K032330 — CT OIA (March 2, 2004)
  • K033865 — IDEIA PCE CHLAMYDIA (January 21, 2004)
  • K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (July 9, 1998)
  • K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM (February 24, 1997)
  • K960850 — ACCESS CHLAMYDIA ASSAY (February 4, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K936054 — IMX SELECT CHLAMYDIA (May 30, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)
  • K935807 — ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (May 19, 1995)

FDA data resources