IDC — Acridine Orange Class I
FDA product code IDC covers "Acridine Orange", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- IDC
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- 510(k) Exempt
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K853187 | Advanced Medical Technology | ACRIDINE ORANGE FLUORESCENT STAIN | Aug 13, 1985 |
| K812212 | Carr-Scarborough Microbiologicals | ACRIDINE ORANGE STAIN | Sep 1, 1981 |
| K810040 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ACRIDINE ORANGE STAIN | Feb 12, 1981 |
| K803304 | Remel | ACRIDINE ORANGE STAIN | Feb 12, 1981 |