DOX — Fluorometer, Lead (Dedicated Instruments) Class II
FDA product code DOX covers "Fluorometer, Lead (Dedicated Instruments)", a Class II medical device regulated under 21 CFR 862.3550. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DOX
- Device Class
- Class II
- Regulation Number
- 862.3550
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K014195 | boston scientific | KAYAK HYDROPHILIC GUIDE WIRES | March 19, 2002 |
| K944226 | msi | MSI PROCEDURE KIT | June 21, 1995 |
| K900822 | national-standard medical products | HYDRO-SIL(TM) COATED GUIDEWIRES | July 17, 1990 |
| K832030 | argon medical | HEPARIN COATED STAINLESS STEEL/TEFLON | September 29, 1983 |