The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Paraprotein Screening.
Device ID | K790667 |
510k Number | K790667 |
Device Name: | CORNING PARAPROTEIN SCREENING |
Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFF |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-06 |
Decision Date | 1979-07-24 |