← FDA Medical Device Classifications

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

JJE · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2160

Classification

FDA Product Code

JJE

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.2160

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

208

Registered establishments

172

Source

Authoritative

FDA Device Classification database

Machine

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