K843684 is an FDA 510(k) clearance for the SIGMA SUDAN BLACK REAGENT 380-1. This device is classified as a Sudan Black B (Class I - General Controls, product code HZZ).
Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on October 31, 1984, 43 days after receiving the submission on September 18, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K843684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | HZZ — Sudan Black B |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |