The following data is part of a premarket notification filed by Blue Ridge Media Co. with the FDA for Blue Ridge Sheep Blood.
Device ID | K820848 |
510k Number | K820848 |
Device Name: | BLUE RIDGE SHEEP BLOOD |
Classification | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment |
Applicant | BLUE RIDGE MEDIA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHW |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-26 |
Decision Date | 1982-04-16 |