The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Eb-vca, Test, Antibody, Fluorescent.
Device ID | K780925 |
510k Number | K780925 |
Device Name: | EB-VCA, TEST, ANTIBODY, FLUORESCENT |
Classification | Antiserum, Fluorescent, Epstein-barr Virus |
Applicant | LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JRY |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-06 |
Decision Date | 1978-06-22 |