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510(k) K033064

MYCOPLASMA IGG by Trinity Biotech USA — Product Code LON

K033064 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "MYCOPLASMA IGG". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. 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
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
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)
  • K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (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 LON

  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (March 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (March 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • K232756 — Colibrí (December 27, 2023)

FDA data resources