The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Phenytoin.
Device ID | K841706 |
510k Number | K841706 |
Device Name: | INNOFLUOR PHENYTOIN |
Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
Applicant | INNOTRON DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LGR |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-05-22 |