The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Total Bilirubin Reagent.
Device ID | K030014 |
510k Number | K030014 |
Device Name: | ATAC TOTAL BILIRUBIN REAGENT |
Classification | Diazo Colorimetry, Bilirubin |
Applicant | ELAN DIAGNOSTICS 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
Contact | Wynn Stocking |
Correspondent | Wynn Stocking ELAN DIAGNOSTICS 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
Product Code | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-02 |
Decision Date | 2003-09-26 |
Summary: | summary |