The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Antisera To Phenobarbital.
Device ID | K811367 |
510k Number | K811367 |
Device Name: | KALLESTAD ANTISERA TO PHENOBARBITAL |
Classification | Enzyme Immunoassay, Phenobarbital |
Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DLZ |
CFR Regulation Number | 862.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-14 |
Decision Date | 1981-05-29 |