← FDA Medical Device Classifications

Olive Oil Emulsion (Turbidimetric), Lipase

CET · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1465

Classification

FDA Product Code
CET
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.1465
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
15
Registered establishments
8

Source

Authoritative
FDA Device Classification database
Machine
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