The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Legionella Pneumophila Igg/igm.
Device ID | K033051 |
510k Number | K033051 |
Device Name: | LEGIONELLA PNEUMOPHILA IGG/IGM |
Classification | Legionella, Spp., Elisa |
Applicant | TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
Contact | Bonnie Dejoy |
Correspondent | Bonnie Dejoy TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
Product Code | MJH |
CFR Regulation Number | 866.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-29 |
Decision Date | 2003-11-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05391516747202 | K033051 | 000 |