The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm2/qm300 Control A Pack.
Device ID | K871342 |
510k Number | K871342 |
Device Name: | QM2/QM300 CONTROL A PACK |
Classification | Multi-analyte Controls, All Kinds (assayed) |
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 | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-02 |
Decision Date | 1987-05-21 |