Product Code: CEQ FDA class 1 21 CFR 862.1575

Molybdenum Blue Method, Phospholipids

Clinical Chemistry

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.

510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K863071 PHOSPHOLIPIDS-E