DOXClass II
Fluorometer, Lead (Dedicated Instruments)
21 CFR 862.3550 / Clinical Toxicology
DOX is the FDA product code for Fluorometer, Lead (Dedicated Instruments), a class II device type, regulated under 21 CFR 862.3550. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DOX
- Device name
- Fluorometer, Lead (Dedicated Instruments)
- Regulation
- 21 CFR 862.3550
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code DOX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1990 | 1 |
| 1995 | 1 |
| 2002 | 1 |
Applicants with the most clearances
Product code DOX| Applicant | Clearances |
|---|---|
| Argon Medical Corp. | 1 |
| Boston Scientific Corporation | 1 |
| Msi, Inc. | 1 |
| National-Standard Medical Products | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
