K954145 is an FDA 510(k) clearance for the WAKO AUTOKIT CH50. This device is classified as a Complement C9, Antigen, Antiserum, Control (Class II - Special Controls, product code DAE).
Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on December 18, 1995, 104 days after receiving the submission on September 5, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K954145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1995 |
| Decision Date | December 18, 1995 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DAE — Complement C9, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |