K820088 is an FDA 510(k) clearance for the AFT SYSTEM PROFICIENCY TESTING PROGRAM. This device is classified as a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBL).
Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1982, 13 days after receiving the submission on January 13, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K820088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1982 |
| Decision Date | January 26, 1982 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |