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LNW · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550

Classification

FDA Product Code

LNW

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.1550

Review panel

OB

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

4

Registered establishments

32

Source

Authoritative

FDA Device Classification database

Machine

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