The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Innofluor(tm) Digitoxin Reagent Set.
Device ID | K913187 |
510k Number | K913187 |
Device Name: | INNOFLUOR(TM) DIGITOXIN REAGENT SET |
Classification | Enzyme Immunoassay, Digitoxin |
Applicant | INTL. BIOCLINICAL, INC. 6040 N. CUTTER CIRCLE SUITE 317 Portland, OR 97217 |
Contact | Craig Smart |
Correspondent | Craig Smart INTL. BIOCLINICAL, INC. 6040 N. CUTTER CIRCLE SUITE 317 Portland, OR 97217 |
Product Code | LFM |
CFR Regulation Number | 862.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-18 |
Decision Date | 1991-09-23 |