The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Electrophoresis Controls-3 In 1.
Device ID | K831263 |
510k Number | K831263 |
Device Name: | ELECTROPHORESIS CONTROLS-3 IN 1 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-18 |
Decision Date | 1983-07-07 |