The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus Support Pack.
Device ID | K855013 |
510k Number | K855013 |
Device Name: | QUANTIMETRIC PLUS SUPPORT PACK |
Classification | Lambda, 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 | DEH |
CFR Regulation Number | 866.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-16 |
Decision Date | 1986-02-26 |