The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Kallestad Qm300 Protein Analysis System.
Device ID | K871339 |
510k Number | K871339 |
Device Name: | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM |
Classification | Calculator/data Processing Module, For Clinical Use |
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 | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-02 |
Decision Date | 1987-05-15 |