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 |