K911885 is an FDA 510(k) clearance for the DADE(R) PROTEIN C ABNORMAL CONTRAL. This device is classified as a Control, Plasma, Abnormal (Class II - Special Controls, product code GGC).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on June 11, 1991, 43 days after receiving the submission on April 29, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K911885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1991 |
| Decision Date | June 11, 1991 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGC — Control, Plasma, Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |