← FDA Medical Device Classifications

Enzymatic Esterase--Oxidase, Cholesterol

CHH · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1175

Classification

FDA Product Code

CHH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.1175

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

230

Registered establishments

82

Source

Authoritative

FDA Device Classification database

Machine

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