The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft System Proficiency Testing Program.
| Device ID | K820088 |
| 510k Number | K820088 |
| Device Name: | AFT SYSTEM PROFICIENCY TESTING PROGRAM |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-13 |
| Decision Date | 1982-01-26 |