Fluorometer, Lead (Dedicated Instruments)
The Fluorometer for Lead (Dedicated Instruments) is a specialized analytical instrument designed specifically to measure lead-related fluorescence signals in patient blood specimens, used for lead exposure screening and toxicology assessment. It is a Class 2 device requiring a 510(k) premarket notification before marketing. The product code is DOX, regulated under 21 CFR 862.3550, within the Clinical Toxicology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- DOX
- Device Class
- FDA class 2
- Regulation Number
- 862.3550
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K014195 | KAYAK HYDROPHILIC GUIDE WIRES | Mar 19, 2002 | Substantially Equivalent | Boston Scientific Corp |
| K944226 | MSI PROCEDURE KIT | Jun 21, 1995 | Substantially Equivalent | Msi, Inc. |
| K900822 | HYDRO-SIL(TM) COATED GUIDEWIRES | Jul 17, 1990 | Substantially Equivalent | National-Standard Medical Products |
| K832030 | HEPARIN COATED STAINLESS STEEL/TEFLON | Sep 29, 1983 | Substantially Equivalent | Argon Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.