← FDA Medical Device Classifications

Container, Specimen, Sterile

FMH · Class I — Low Risk (general controls) · Pathology · 21 CFR 864.3250

Classification

FDA Product Code

FMH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.3250

Review panel

HO

Medical specialty

Pathology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

23

Registered establishments

287

Source

Authoritative

FDA Device Classification database

Machine

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