The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm2/qm300 Buffer And Diluent Pack.
| Device ID | K871343 |
| 510k Number | K871343 |
| Device Name: | QM2/QM300 BUFFER AND DILUENT PACK |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jan Petersen |
| Correspondent | Jan Petersen KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-02 |
| Decision Date | 1987-05-15 |