The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Trisedta-borate Electrophoresis Film Aga.
Device ID | K790943 |
510k Number | K790943 |
Device Name: | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA |
Classification | Assay, Carboxyhemoglobin |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GHS |
CFR Regulation Number | 864.7425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-18 |
Decision Date | 1979-06-22 |