The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rheumogen Test System.
Device ID | K790012 |
510k Number | K790012 |
Device Name: | RHEUMOGEN TEST SYSTEM |
Classification | System, Test, Rheumatoid Factor |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-02 |
Decision Date | 1979-01-26 |