The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Immunoglobulin A Reagent System.
Device ID | K800211 |
510k Number | K800211 |
Device Name: | IMMUNOGLOBULIN A REAGENT SYSTEM |
Classification | Iga, Antigen, Antiserum, Control |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CZP |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-01 |
Decision Date | 1980-02-19 |