K896483 is an FDA 510(k) clearance for the QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK. This device is classified as a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEB).
Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on December 1, 1989, 18 days after receiving the submission on November 13, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5620.
| 510(k) Number | K896483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1989 |
| Decision Date | December 01, 1989 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5620 |