The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innofluor Phenobarbital Assay System.
Device ID | K972330 |
510k Number | K972330 |
Device Name: | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM |
Classification | Fluorescence Polarization Immunoassay, Phenobarbital |
Applicant | OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
Contact | Lynda M Taylor |
Correspondent | Lynda M Taylor OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
Product Code | LGQ |
CFR Regulation Number | 862.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-23 |
Decision Date | 1997-07-14 |
Summary: | summary |