The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Troponin I Ultra (tniu) Assay, Model 30 448.
Device ID | K063243 |
510k Number | K063243 |
Device Name: | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 |
Classification | Immunoassay Method, Troponin Subunit |
Applicant | BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
Contact | Nikita S Mapp |
Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
Product Code | MMI |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-26 |
Decision Date | 2007-12-14 |
Summary: | summary |