K810040 is an FDA 510(k) clearance for the ACRIDINE ORANGE STAIN. This device is classified as a Acridine Orange (Class I - General Controls, product code IDC).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 12, 1981, 34 days after receiving the submission on January 9, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K810040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1981 |
| Decision Date | February 12, 1981 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | IDC — Acridine Orange |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |