← FDA Medical Device Classifications

Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

LKL · Class I — Low Risk (general controls) · Immunology · 21 CFR 866.5420

Classification

FDA Product Code

LKL

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 866.5420

Review panel

IM

Medical specialty

Immunology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

11

Registered establishments

18

Source

Authoritative

FDA Device Classification database

Machine

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