The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innotron Innofluor Pheytoin Reagent Set.
Device ID | K872563 |
510k Number | K872563 |
Device Name: | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET |
Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
Applicant | INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
Contact | Buck, Ph.d |
Correspondent | Buck, Ph.d INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
Product Code | LGR |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-24 |
Decision Date | 1987-08-21 |