The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Kallestad Quantafluor Antithyroid Antibody Test.
| Device ID | K881933 |
| 510k Number | K881933 |
| Device Name: | KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-10 |
| Decision Date | 1988-06-06 |