The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Citrate Agar Gel And Buffer Set.
Device ID | K790944 |
510k Number | K790944 |
Device Name: | CITRATE AGAR GEL AND BUFFER SET |
Classification | System, Analysis, Electrophoretic Hemoglobin |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JBD |
CFR Regulation Number | 864.7440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-18 |
Decision Date | 1979-06-28 |