The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Rubella Bio-bead Screen Kit.
Device ID | K791610 |
510k Number | K791610 |
Device Name: | RUBELLA BIO-BEAD SCREEN KIT |
Classification | Antigen, Ha (including Ha Control), Rubella |
Applicant | LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GOL |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-11-13 |