The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Glutamic Acid Decarboxylase Antibody Kit.
| Device ID | K051061 |
| 510k Number | K051061 |
| Device Name: | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT |
| Classification | Autoantibodies, Glutamic Acid Decarboxylase (gad) |
| Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Contact | Meather Viele |
| Correspondent | Meather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
| Product Code | NWG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR67100 | K051061 | 000 |