K842537 is an FDA 510(k) clearance for the VON WILLEBRAND FACTOR ANTIGEN SCREEN. This device is classified as a Crystal Violet For Histology (Class I - General Controls, product code ICF).
Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984, 95 days after receiving the submission on June 28, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K842537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1984 |
| Decision Date | October 01, 1984 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | ICF — Crystal Violet For Histology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |