FDA product code DOX: Fluorometer, Lead (Dedicated Instruments)
DOX is the FDA product code for fluorometer, lead (dedicated instruments). It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DOX, from 4 different applicants. The average 510(k) review took 157 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Fluorometer, Lead (Dedicated Instruments) |
| Device class | Class II |
| Regulation | 21 CFR 862.3550 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every DOX clearance
Top DOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 1 | 2002-03-19 |
| Msi, Inc. | 1 | 1995-06-21 |
| National-Standard Medical Products | 1 | 1990-07-17 |
| Argon Medical Corp. | 1 | 1983-09-29 |
Most recent DOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K014195 | Boston Scientific Corp | KAYAK HYDROPHILIC GUIDE WIRES | 2002-03-19 | 88 |
| K944226 | Msi, Inc. | MSI PROCEDURE KIT | 1995-06-21 | 295 |
| K900822 | National-Standard Medical Products | HYDRO-SIL(TM) COATED GUIDEWIRES | 1990-07-17 | 146 |
| K832030 | Argon Medical Corp. | HEPARIN COATED STAINLESS STEEL/TEFLON | 1983-09-29 | 98 |
Recalls for DOX devices
openFDA lists no recalls for product code DOX.
Frequently asked questions
What is FDA product code DOX?
DOX is the FDA product code for fluorometer, lead (dedicated instruments). It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel.
What device class is DOX?
Class II, regulation 21 CFR 862.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOX?
Across 4 cleared submissions the average was 157 days from receipt to decision (median 122).
Which companies have the most DOX clearances?
Boston Scientific Corp (1); Msi, Inc. (1); National-Standard Medical Products (1); Argon Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOX
- Run a recall and safety report across every DOX manufacturer
- Watch product code DOX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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