The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm300 Igg Antibody Pack.
Device ID | K871340 |
510k Number | K871340 |
Device Name: | QM300 IGG ANTIBODY PACK |
Classification | Igg, Antigen, Antiserum, Control |
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 | DEW |
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 | 1987-04-22 |