The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Insulin Autoantibody (iaa) Assay Kit.
Device ID | K070183 |
510k Number | K070183 |
Device Name: | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT |
Classification | Insulin Autoantibody Kit |
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 | OCN |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-19 |
Decision Date | 2007-07-13 |