The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Phenobarbital.
Device ID | K934388 |
510k Number | K934388 |
Device Name: | QMS PHENOBARBITAL |
Classification | Nephelometric Inhibition Immunoassay, Phenobarbital |
Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
Contact | Andris Indriksons |
Correspondent | Andris Indriksons SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
Product Code | LFN |
CFR Regulation Number | 862.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-09 |
Decision Date | 1994-02-25 |