The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Ia-2 Autoantibody Ria Assay Kit.
Device ID | K073590 |
510k Number | K073590 |
Device Name: | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT |
Classification | Tyrosine Phosphatase (ia-2) Autoantibody Assay |
Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
Contact | Heather Viele |
Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
Product Code | OIF |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-20 |
Decision Date | 2008-04-10 |