← FDA Medical Device Classifications

Formulations, Balanced Salt Solutions

KIP · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.2875

Classification

FDA Product Code

KIP

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.2875

Review panel

PA

Medical specialty

Hematology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

17

Registered establishments

18

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown