The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Easy Wash Elisa Plates.
Device ID | K872273 |
510k Number | K872273 |
Device Name: | CORNING EASY WASH ELISA PLATES |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
Contact | Barbara L Mullin |
Correspondent | Barbara L Mullin CORNING MEDICAL & SCIENTIFIC 275 RIVER ST. Oneonta, NY 13820 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-15 |
Decision Date | 1987-07-07 |