K941346 is an FDA 510(k) clearance for the PLASMINOGEN RID TEST KIT. This device is classified as a Plasminogen, Antigen, Antiserum, Control (Class I - General Controls, product code DDX).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 9, 1994, 172 days after receiving the submission on March 21, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5715.
| 510(k) Number | K941346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1994 |
| Decision Date | September 09, 1994 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDX — Plasminogen, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5715 |