← FDA Medical Device Classifications

Sampler, Amniotic Fluid (Amniocentesis Tray)

HIO · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.1550

Classification

FDA Product Code

HIO

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 884.1550

Review panel

OB

Medical specialty

Obstetrics/Gynecology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

20

Registered establishments

41

Source

Authoritative

FDA Device Classification database

Machine

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