Molybdenum Blue Method, Phospholipids
The Molybdenum Blue Method Phospholipids Test is a clinical chemistry device that quantifies phospholipids in biological specimens using the molybdenum blue colorimetric reaction, in which phosphate released from phospholipid hydrolysis reacts with molybdate to yield a blue-colored complex measurable spectrophotometrically. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEQ, regulated under 21 CFR 862.1575, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CEQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863071 | PHOSPHOLIPIDS-E | Sep 09, 1986 | Substantially Equivalent | J. D. Assoc. |