Product Code: CEL FDA class 1 21 CFR 862.1575

Ammonium Molybdate And Ammonium Vanadate, Phospholipids

Clinical Chemistry

The Ammonium Molybdate and Ammonium Vanadate Phospholipids Test is a clinical chemistry device that measures phospholipid concentrations in biological specimens using a colorimetric reaction with ammonium molybdate and ammonium vanadate, used in lipid metabolism research and clinical evaluation of lipid disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEL, regulated under 21 CFR 862.1575, within the Clinical Chemistry medical specialty. No special flags apply to this device.

510(k)s
3
FEI Numbers
2
Registration Numbers
2
Unique Applicants
3
Years Active
11

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Basic Information

Product Code
CEL
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 3 510(k) clearances via K numbers.

K Number Device Name
K905829 DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
K884169 DU PONT ANALYST THYROID ROTOR
K801076 WAKO PHOSPHOLIPIDS TEST

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.