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Enzymatic Method, Ammonia

JIF · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1065

Classification

FDA Product Code

JIF

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.1065

Review panel

CH

Medical specialty

Clinical Chemistry

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

30

Registered establishments

18

Source

Authoritative

FDA Device Classification database

Machine

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