FDA product code CFD: Sulfophosphovanillin, Colorimetry, Total Lipids
CFD is the FDA product code for sulfophosphovanillin, colorimetry, total lipids. It is a Class I device, regulated under 21 CFR 862.1470 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under CFD, from 4 different applicants. The average 510(k) review took 19 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Sulfophosphovanillin, Colorimetry, Total Lipids |
| Device class | Class I |
| Regulation | 21 CFR 862.1470 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFD clearance
Top CFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. D. Assoc. | 1 | 1986-09-09 |
| Technostics Intl. | 1 | 1986-01-24 |
| Anco Medical Reagents & Assoc. | 1 | 1982-03-11 |
| Bio-Analytics Laboratories, Inc. | 1 | 1981-12-31 |
Most recent CFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863073 | J. D. Assoc. | TOTAL LIPIDS | 1986-09-09 | 28 |
| K860112 | Technostics Intl. | TOTAL LIPIDS REAGENT SET | 1986-01-24 | 11 |
| K820500 | Anco Medical Reagents & Assoc. | TOTAL LIPID REAGENT SET | 1982-03-11 | 16 |
| K813469 | Bio-Analytics Laboratories, Inc. | LIPID PROFILE | 1981-12-31 | 20 |
Recalls for CFD devices
openFDA lists no recalls for product code CFD.
Frequently asked questions
What is FDA product code CFD?
CFD is the FDA product code for sulfophosphovanillin, colorimetry, total lipids. It is a Class I device, regulated under 21 CFR 862.1470 and reviewed by the Clinical Chemistry panel.
What device class is CFD?
Class I, regulation 21 CFR 862.1470. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFD?
Across 4 cleared submissions the average was 19 days from receipt to decision (median 18).
Which companies have the most CFD clearances?
J. D. Assoc. (1); Technostics Intl. (1); Anco Medical Reagents & Assoc. (1); Bio-Analytics Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CFD
- Run a recall and safety report across every CFD manufacturer
- Watch product code CFD 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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