The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rubella Elisa Reagents Rubella Igg Anti.
Device ID | K802102 |
510k Number | K802102 |
Device Name: | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI |
Classification | Antigen, Ha (including Ha Control), Rubella |
Applicant | CALBIOCHEM-BEHRING CORP. 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 | 1980-09-03 |
Decision Date | 1980-12-18 |