The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Autoantibody Reagents, Aft System Ii.
| Device ID | K790280 |
| 510k Number | K790280 |
| Device Name: | AUTOANTIBODY REAGENTS, AFT SYSTEM II |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-13 |
| Decision Date | 1979-04-23 |