The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus C4 Reagent Kit.
Device ID | K855012 |
510k Number | K855012 |
Device Name: | QUANTIMETRIC PLUS C4 REAGENT KIT |
Classification | Complement C4, Antigen, Antiserum, Control |
Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Quinlan Smith |
Correspondent | Quinlan Smith KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | DBI |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-16 |
Decision Date | 1986-02-26 |