The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor Phenytoin Manual Fpia Reagent Set.
Device ID | K895827 |
510k Number | K895827 |
Device Name: | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET |
Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
Applicant | INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland, OR 97202 |
Contact | Craig Smart |
Correspondent | Craig Smart 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 | 1989-10-02 |
Decision Date | 1989-10-31 |