K890564 is an FDA 510(k) clearance for the SPQ(TM) ANTIBODY REAGENT SET II FOR C4. This device is classified as a Complement C4, Antigen, Antiserum, Control (Class II - Special Controls, product code DBI).
Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on February 17, 1989, 24 days after receiving the submission on January 24, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K890564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1989 |
| Decision Date | February 17, 1989 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBI — Complement C4, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |